{ "FullStudy":{ "Rank":218283, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510327", "OrgStudyIdInfo":{ "OrgStudyId":"S2046B" }, "Organization":{ "OrgFullName":"Boston Scientific Corporation", "OrgClass":"INDUSTRY" }, "BriefTitle":"PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK)", "OfficialTitle":"PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions - Pharmacokinetics Sub-trial", "Acronym":"PLATINUM PK" }, "StatusModule":{ "StatusVerifiedDate":"March 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"October 2009" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2010", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 21, 2011", "StudyFirstSubmitQCDate":"January 11, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 16, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"January 16, 2012", "ResultsFirstSubmitQCDate":"March 2, 2012", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"April 5, 2012", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 13, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 26, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Boston Scientific Corporation", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. The lesions are located in vessels that are average-sized.", "DetailedDescription":"The wide-spread use of drug-eluting stents (DES) has evolved as standard of care in de novo lesions. The proposed study will evaluate the safety and effectiveness of PROMUS Element for the treatment of de novo atherosclerotic lesions in native coronary arteries. The study design is consistent with the draft guidance for industry titled, \"Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies\" (March 2008).\n\nDuring the trial, thienopyridines must be administered according to the 2007 American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines, which recommended that clopidogrel (75 mg daily) or ticlopidine (250 mg twice daily) be prescribed after stent implantation for at least 6 months in all patients, and for at least 12 months in patients who are not at high risk of bleeding. For sites in the United States, the use of prasugrel is not allowed as part of the PLATINUM Clinical Trial. For sites in other countries, prasugrel may be prescribed according to its approved dosing in countries in which it is available. For patients taking aspirin daily a loading dose is recommended; for patients who have not been taking aspirin daily, aspirin must be administered as a loading dose. Patients continue to take aspirin indefinitely to reduce the risk of thrombosis.\n\nThis PLATINUM Pharmacokinetics (PK) study is a sub-trial associated with the PLATINUM Workhorse Randomized Controlled Trial, which is registered under NCT00823212. PLATINUM PK was designed to evaluate the elution of everolimus from the PROMUS Element everolimus-eluting stent." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Coronary Artery Disease" ] }, "KeywordList":{ "Keyword":[ "drug-eluting stents", "DES", "atherosclerotic" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"22", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"PROMUS Element", "ArmGroupType":"Experimental", "ArmGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique. Total loaded dose of everolimus per stent is dependent on stent size and in this study the administered dose ranged from 60.1 µg to 138.6 µg per stent. Note that the total dose of everolimus administered to a patient is based on the number of stents received and the size of the stent(s). The total dose received per patient ranged from 60.1 µg to 197.8 µg.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: PROMUS Element Everolimus-Eluting Coronary Stent System", "Drug: Aspirin", "Drug: Thienopyridine" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"PROMUS Element Everolimus-Eluting Coronary Stent System", "InterventionDescription":"PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PROMUS Element" ] } },{ "InterventionType":"Drug", "InterventionName":"Aspirin", "InterventionDescription":"Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PROMUS Element" ] } },{ "InterventionType":"Drug", "InterventionName":"Thienopyridine", "InterventionDescription":"Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PROMUS Element" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "A brand name for clopidogrel is PLAVIX.", "A brand name for ticlopidine is TICLID." ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Maximum Observed Everolimus Blood Concentration (Cmax)", "PrimaryOutcomeDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent", "PrimaryOutcomeTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Area Under the Concentration Versus Time Curve (AUC 0-t) Everolimus", "SecondaryOutcomeDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent; t is the last time at which concentration can be quantified", "SecondaryOutcomeTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours" },{ "SecondaryOutcomeMeasure":"Area Under the Concentration Versus Time Curve (AUC 0-24), Everolimus", "SecondaryOutcomeDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent", "SecondaryOutcomeTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours" },{ "SecondaryOutcomeMeasure":"Area Under the Concentration Versus Time Curve (AUC 0-infinity) Everolimus", "SecondaryOutcomeDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after implantation of the last study stent.", "SecondaryOutcomeTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours" },{ "SecondaryOutcomeMeasure":"Time of Occurrence of Maximum Everolimus Concentration (Tmax)", "SecondaryOutcomeDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent", "SecondaryOutcomeTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours" },{ "SecondaryOutcomeMeasure":"Terminal Phase Half-life (t1/2) Everolimus", "SecondaryOutcomeDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.", "SecondaryOutcomeTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours" },{ "SecondaryOutcomeMeasure":"Total Blood Clearance - Everolimus (CL)", "SecondaryOutcomeDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.", "SecondaryOutcomeTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours" },{ "SecondaryOutcomeMeasure":"All Death", "SecondaryOutcomeDescription":"Number of participants no longer alive", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"Myocardial Infarction (MI) Related to the Target Vessel", "SecondaryOutcomeDescription":"New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase (CK) MB or troponin >normal; if no new Q-waves total CK levels >3× normal (peri-percutaneous coronary intervention [PCI]) or >2× normal (spontaneous) with elevated CK-MB or troponin >3× normal (peri-PCI) or >2× normal (spontaneous) plus at least one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× normal", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"Target Vessel Revascularization (TVR)", "SecondaryOutcomeDescription":"TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"Target Lesion Revascularization (TLR)", "SecondaryOutcomeDescription":"TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition", "SecondaryOutcomeDescription":"DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).", "SecondaryOutcomeTimeFrame":"24 hours" },{ "SecondaryOutcomeMeasure":"Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition", "SecondaryOutcomeDescription":"DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).", "SecondaryOutcomeTimeFrame":">24 hours-30 days" },{ "SecondaryOutcomeMeasure":"Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition", "SecondaryOutcomeDescription":"DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).", "SecondaryOutcomeTimeFrame":">30 days-1 year" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatient must be at least 18 years of age\nPatient (or legal guardian) understands study requirements and treatment procedures and provides written informed consent before any study-specific tests or procedures are performed\nFor patients less than 20 years of age enrolled at a Japanese site, patient and patient's legal representative must provide written informed consent before any study-specific tests or procedures are performed\nPatient is eligible for percutaneous coronary intervention (PCI)\nPatient has documented stable angina pectoris or documented silent ischemia; or unstable angina pectoris\nPatient is an acceptable candidate for coronary artery bypass grafting (CABG)\nPatient has a left ventricular ejection fraction (LVEF) >=30% as measured within 30 days prior to enrollment\nPatient is willing to comply with all protocol-required follow-up evaluations\n\nAngiographic Inclusion Criteria (visual estimate):\n\n• Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) >=2.50 mm and <=4.25 mm. Target lesion length must measure (by visual estimate) <=24 mm. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >=50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1.\n\nExclusion Criteria:\n\nPatient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI)\n\nPatient has had a known diagnosis of recent MI (ie, within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure as follows.\n\nPatients are excluded if any of the following criteria are met at time of the index procedure.\n\nIf creatine kinase-myoglobin band(CK-MB) >2× upper limit of normal (ULN), the patient is excluded regardless of CK Total.\nIf CK-MB is 1-2× ULN, the patient is excluded if the CK Total is >2× ULN.\n\nIf CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at time of index procedure.\n\nTroponin >1× ULN with at least one of the following.\nPatient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, >1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block [LBBB]);\nDevelopment of pathological Q waves in the ECG; or\nImaging evidence of new loss of viable myocardium or new regional wall motion abnormality.\n\nNote: For patients with unstable angina or patients who have had a recent MI, CK Total/CK MB (or Troponin if CK Total/CK MB are not used) must be documented prior to enrolling/randomizing the patient.\n\nPatient has received an organ transplant or is on a waiting list for an organ transplant\nPatient is receiving or scheduled to receive chemotherapy within 30 days before or after index procedure\nPatient is receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)\nPatient is receiving chronic (>=72 hours) anticoagulation therapy (eg, heparin, coumadin) for indications other than acute coronary syndrome\nPatient has platelet count <100,000 cells/mm3 or >700,000 cells/mm3\nPatient has white blood cell (WBC) count <3,000 cells/mm3\nPatient has documented or suspected liver disease, including laboratory evidence of hepatitis\nPatient is on dialysis or has known renal insufficiency (ie, estimated creatinine clearance <50 ml/min by the Cockcroft Gault formula, or [(140-age)*lean body weight (in kg)]/[plasma creatinine (mg/dl)*72])\nPatient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions\nPatient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol\nTarget vessel(s) or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to index procedure\nTarget vessel(s) has been treated within 10 mm proximal or distal to target lesion (by visual estimate) with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to index procedure\nNon-target vessel or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to index procedure\nPlanned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement\nPlanned PCI or CABG after index procedure\nPatient previously treated at any time with coronary intravascular brachytherapy\nPatient has a known allergy to the study stent system or protocol-required concomitant medications (eg, stainless steel, platinum, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated\nPatient has active peptic ulcer or active gastrointestinal (GI) bleeding\n\nPatient has one of the following.\n\nOther serious medical illness (eg, cancer, congestive heart failure) that may reduce life expectancy to less than 24 months\nCurrent problems with substance abuse (eg, alcohol, cocaine, heroin, etc.)\nPlanned procedure that may cause non-compliance with protocol or confound data interpretation\nPatient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint\nPatient intends to participate in another investigational drug or device clinical trial within 12 months after index procedure\nPatient with known intention to procreate within 12 months after index procedure (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.)\nPatient is a woman who is pregnant or nursing (A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)\nPatient has more than 2 target lesions, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure\n\nAngiographic Exclusion Criteria (visual estimate):\n\nTarget lesion meets any of the following criteria:\n\nAorto-ostial location (ie, lesion located within 5 mm of ostium by visual estimate)\nLeft main location\nLocated within 5 mm of origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate\nLocated within a saphenous vein graft or arterial graft\nWill be accessed via a saphenous vein graft or arterial graft\nInvolves a side branch >=2.0 mm in diameter by visual estimate\nInvolves a clinically significant side branch <2.0 mm in diameter by visual estimate that has a clinically significant stenosis at the ostium\nTIMI flow 0 (total occlusion) or TIMI flow 1 prior to wire crossing\nExcessive tortuosity proximal to or within the lesion\nExtreme angulation proximal to or within the lesion\nTarget lesion and/or target vessel proximal to the target lesion is moderately to severely calcified by visual estimate\nRestenotic from previous intervention\nThrombus, or possible thrombus, present in target vessel\n\nNon-target lesion to be treated during the index procedure meets any of the following criteria:\n\nLocated within the target vessel\nLocated within a bypass graft (venous or arterial)\nLeft main location\nChronic total occlusion\nInvolves a complex bifurcation (eg, bifurcations requiring treatment with more than 1 stent)\nRestenotic from previous intervention\nPatient has unprotected left main coronary artery disease (>50% diameter stenosis)\nPatient has protected left main coronary artery disease and a target lesion in the LAD or LCX\nPatient has an additional clinically significant lesion(s) in target vessel for which an intervention within 12 months after the index procedure is likely to be required\nPatient has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate) Note: Multiple focal stenoses will be considered as a single lesion if they can be completely covered with 1 stent.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Peter M. Maurer, MPH", "OverallOfficialAffiliation":"Boston Scientific Corporation", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Medical Center of the Rockies (Loveland)", "LocationCity":"Loveland", "LocationState":"Colorado", "LocationZip":"80538", "LocationCountry":"United States" },{ "LocationFacility":"Cardiac & Vascular Research Center of Northern Michigan", "LocationCity":"Petoskey", "LocationState":"Michigan", "LocationZip":"49770", "LocationCountry":"United States" },{ "LocationFacility":"Saiseikai Yokohama-City Eastern Hospital", "LocationCity":"Yokohama City", "LocationState":"Kanagawa-ken", "LocationCountry":"Japan" },{ "LocationFacility":"Tokyo Women's Medical University Hospital", "LocationCity":"Shinjuku-ku", "LocationState":"Tokyo-to", "LocationCountry":"Japan" },{ "LocationFacility":"Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases", "LocationCity":"Fuchu-shi", "LocationState":"Tokyo", "LocationCountry":"Japan" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Undecided", "IPDSharingDescription":"The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)." } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"From October 9, 2009 to February 9, 2010 there were 11 patients enrolled at 2 investigative sites in the United States and 11 patients enrolled at 3 sites in Japan. All enrolled patients received a PROMUS Element study stent.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"PROMUS Element", "FlowGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"22" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"22" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"PROMUS Element", "BaselineGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"22" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"13" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"64.6", "BaselineMeasurementSpread":"9.5" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"18" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" } ] } } ] } },{ "BaselineClassTitle":"Japan", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Cardiac History", "BaselineMeasureDescription":"The same participant may be included in more than one category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Previous Percutaneous Coronary Intervention (PCI)", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" } ] } } ] } },{ "BaselineClassTitle":"Previous Coronary Artery Bypass Graft (CABG)", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" } ] } } ] } },{ "BaselineClassTitle":"Previous Myocardial Infarction (MI)", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" } ] } } ] } },{ "BaselineClassTitle":"Stable Angina", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"15" } ] } } ] } },{ "BaselineClassTitle":"Unstable Angina", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" } ] } } ] } },{ "BaselineClassTitle":"Silent Ischemia", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" } ] } } ] } },{ "BaselineClassTitle":"History of Multivessel Disease", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Cardiac History - Left Ventricular Ejection Fraction", "BaselineMeasureDescription":"Left ventricular ejection fraction (LVEF) is an assessment (fraction) of the amount of blood emptied from the left ventricle during systolic contraction, which is indicative of global ventricular function.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Percent (of blood emptied)", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"59.64", "BaselineMeasurementSpread":"10.09" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Height", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Centimeters", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"165.57", "BaselineMeasurementSpread":"12.55" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Weight", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Kilograms", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"73.68", "BaselineMeasurementSpread":"19.60" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Body Mass Index", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg/m^2", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"26.52", "BaselineMeasurementSpread":"4.79" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Cardiac Risk Factors", "BaselineMeasureDescription":"The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Smoking, ever", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"14" } ] } } ] } },{ "BaselineClassTitle":"Medically Treated Diabetes", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" } ] } } ] } },{ "BaselineClassTitle":"Hyperlipidemia Requiring Medication", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" } ] } } ] } },{ "BaselineClassTitle":"Hypertension Requiring Medication", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"18" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Comorbidities", "BaselineMeasureDescription":"The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"History of Transient Ischemic Attack", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" } ] } } ] } },{ "BaselineClassTitle":"History of Cerebrovascular Accident", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" } ] } } ] } },{ "BaselineClassTitle":"History of Peripheral Vascular Disease", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" } ] } } ] } },{ "BaselineClassTitle":"History of Renal Disease", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Lesion Characteristic: Target Lesion Vessel", "BaselineMeasureDescription":"24 lesions in 22 participants were treated.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Lesions", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Left Anterior Descending Artery", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" } ] } } ] } },{ "BaselineClassTitle":"Left Circumflex Artery", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" } ] } } ] } },{ "BaselineClassTitle":"Right Coronary Artery", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"13" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Lesion Characteristic: Lesion Location", "BaselineMeasureDescription":"24 lesions treated in 22 participants.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Proximal", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" } ] } } ] } },{ "BaselineClassTitle":"Mid", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"13" } ] } } ] } },{ "BaselineClassTitle":"Distal", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Lesion Characteristics: Reference Vessel Diameter, Minimum Lumen Diameter, Length", "BaselineMeasureDescription":"There were 24 lesions treated in 22 participants.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"millimeters", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Reference Vessel Diameter", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2.64", "BaselineMeasurementSpread":"0.46" } ] } } ] } },{ "BaselineClassTitle":"Minimum Lumen Diameter", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0.73", "BaselineMeasurementSpread":"0.38" } ] } } ] } },{ "BaselineClassTitle":"Lesion Length", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12.11", "BaselineMeasurementSpread":"4.69" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Lesion Characteristic-Percent Diameter Stenosis", "BaselineMeasureDescription":"There were 24 lesions treated in 22 participants.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Percent", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"73.15", "BaselineMeasurementSpread":"11.24" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Lesion Characteristics", "BaselineMeasureDescription":"There were 24 lesions treated in 22 participants. The same lesion may be included in more than one category, therefore the number of lesions for this baseline measure does not equal the total number of lesions in the group.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Lesions", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Eccentric Lesion", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"13" } ] } } ] } },{ "BaselineClassTitle":"Bend >45 Degrees", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"13" } ] } } ] } },{ "BaselineClassTitle":"Bend >90 Degrees", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" } ] } } ] } },{ "BaselineClassTitle":"Tortuosity, any", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"Calcification, any", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" } ] } } ] } },{ "BaselineClassTitle":"Bifurcation", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class", "BaselineMeasureDescription":"Type A: minimally complex, readily accessible, non angulated, smooth contour, little to no calcification, less than totally occlusive, not ostial in location, no major side branch involvement, absence of thrombus.\n\nType B: moderately complex, eccentric, moderate tortuosity and angulation, moderate or heavy calcification, total occlusion < 3 months old, ostial in location, presence of thrombus; type B1 has one adverse characteristic and B2 has ≥2. Type C: severely complex, diffuse, excessive tortuosity and angulation, total occlusions > 3 months old, degenerated vein grafts and friable lesions.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Lesions", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"A", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"B1", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" } ] } } ] } },{ "BaselineClassTitle":"B2", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"15" } ] } } ] } },{ "BaselineClassTitle":"C", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow", "BaselineMeasureDescription":"24 lesions treated in 22 participants. Thrombolysis In Myocardial Infarction (TIMI)0 - No perfusion; TIMI 1 - Penetration with minimal perfusion; TIMI 2 - Partial perfusion; TIMI 3 - Complete perfusion", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Lesions", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"TIMI 0", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } },{ "BaselineClassTitle":"TIMI 1", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } },{ "BaselineClassTitle":"TIMI 2", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } },{ "BaselineClassTitle":"TIMI 3", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"24" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Maximum Observed Everolimus Blood Concentration (Cmax)", "OutcomeMeasureDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent", "OutcomeMeasurePopulationDescription":"The analysis groups reported here had 3 or more subjects.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng/mL", "OutcomeMeasureTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Everolimus Dose of 95.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Everolimus Dose of 102.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Everolimus Dose of 138.6 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"3" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.71", "OutcomeMeasurementSpread":"0.09" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.67", "OutcomeMeasurementSpread":"0.15" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.91", "OutcomeMeasurementSpread":"0.20" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Area Under the Concentration Versus Time Curve (AUC 0-t) Everolimus", "OutcomeMeasureDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent; t is the last time at which concentration can be quantified", "OutcomeMeasurePopulationDescription":"The analysis groups reported here had 3 or more subjects.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng*hr/mL", "OutcomeMeasureTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Everolimus Dose of 95.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Everolimus Dose of 102.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Everolimus Dose of 138.6 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"3" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.27", "OutcomeMeasurementSpread":"4.97" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.45", "OutcomeMeasurementSpread":"5.26" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"10.87", "OutcomeMeasurementSpread":"7.36" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Area Under the Concentration Versus Time Curve (AUC 0-24), Everolimus", "OutcomeMeasureDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent", "OutcomeMeasurePopulationDescription":"The analysis groups reported here had 3 or more subjects.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng*hr/mL", "OutcomeMeasureTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Everolimus Dose of 95.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Everolimus Dose of 102.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Everolimus Dose of 138.6 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"3" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.83", "OutcomeMeasurementSpread":"2.03" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.14", "OutcomeMeasurementSpread":"1.10" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9.51", "OutcomeMeasurementSpread":"0.64" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Area Under the Concentration Versus Time Curve (AUC 0-infinity) Everolimus", "OutcomeMeasureDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after implantation of the last study stent.", "OutcomeMeasurePopulationDescription":"Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; AUC0-∞ could be inaccurately determined for a subset of samples. AUC0-∞ determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine AUC0-∞.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng*hr/mL", "OutcomeMeasureTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Everolimus Dose of 95.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Everolimus Dose of 102.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Everolimus Dose of 138.6 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"3" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"19.26", "OutcomeMeasurementSpread":"11.69" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12.95", "OutcomeMeasurementSpread":"2.05" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"60.74", "OutcomeMeasurementSpread":"25.95" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time of Occurrence of Maximum Everolimus Concentration (Tmax)", "OutcomeMeasureDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent", "OutcomeMeasurePopulationDescription":"Analysis groups reported here had 3 or more subjects.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"hours", "OutcomeMeasureTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Everolimus Dose of 95.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Everolimus Dose of 102.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Everolimus Dose of 138.6 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"3" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.47", "OutcomeMeasurementSpread":"0.03" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.62", "OutcomeMeasurementSpread":"0.23" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.52", "OutcomeMeasurementSpread":"0.09" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Terminal Phase Half-life (t1/2) Everolimus", "OutcomeMeasureDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.", "OutcomeMeasurePopulationDescription":"Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; half-life could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine half-life.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Hours", "OutcomeMeasureTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Everolimus Dose of 95.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Everolimus Dose of 102.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Everolimus Dose of 138.6 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"3" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"34.19", "OutcomeMeasurementSpread":"20.81" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"22.83", "OutcomeMeasurementSpread":"7.20" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"136.06", "OutcomeMeasurementSpread":"62.08" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Total Blood Clearance - Everolimus (CL)", "OutcomeMeasureDescription":"Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.", "OutcomeMeasurePopulationDescription":"Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; CL could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine CL value.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"L/h", "OutcomeMeasureTimeFrame":"Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Everolimus Dose of 95.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Everolimus Dose of 102.4 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Everolimus Dose of 138.6 µg", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"3" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6445", "OutcomeMeasurementSpread":"3924" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8044", "OutcomeMeasurementSpread":"1276" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2511", "OutcomeMeasurementSpread":"1073" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"All Death", "OutcomeMeasureDescription":"Number of participants no longer alive", "OutcomeMeasurePopulationDescription":"Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants who died", "OutcomeMeasureTimeFrame":"6 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PROMUS Element", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Myocardial Infarction (MI) Related to the Target Vessel", "OutcomeMeasureDescription":"New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase (CK) MB or troponin >normal; if no new Q-waves total CK levels >3× normal (peri-percutaneous coronary intervention [PCI]) or >2× normal (spontaneous) with elevated CK-MB or troponin >3× normal (peri-PCI) or >2× normal (spontaneous) plus at least one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× normal", "OutcomeMeasurePopulationDescription":"Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"6 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PROMUS Element", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Target Vessel Revascularization (TVR)", "OutcomeMeasureDescription":"TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.", "OutcomeMeasurePopulationDescription":"Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"6 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PROMUS Element", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Target Lesion Revascularization (TLR)", "OutcomeMeasureDescription":"TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.", "OutcomeMeasurePopulationDescription":"Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"6 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PROMUS Element", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition", "OutcomeMeasureDescription":"DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).", "OutcomeMeasurePopulationDescription":"Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"24 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PROMUS Element", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition", "OutcomeMeasureDescription":"DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).", "OutcomeMeasurePopulationDescription":"Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":">24 hours-30 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PROMUS Element", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition", "OutcomeMeasureDescription":"DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).", "OutcomeMeasurePopulationDescription":"Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":">30 days-1 year", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PROMUS Element", "OutcomeGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"6 months", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"PROMUS Element", "EventGroupDescription":"Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"22", "EventGroupOtherNumAffected":"9", "EventGroupOtherNumAtRisk":"22" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Gastritis erosive", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA (12.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"22" } ] } },{ "SeriousEventTerm":"Vascular pseudoaneurysm", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA (12.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"22" } ] } },{ "SeriousEventTerm":"Synovial cyst", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"MedDRA (12.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"22" } ] } },{ "SeriousEventTerm":"Pulmonary embolism", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA (12.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"22" } ] } },{ "SeriousEventTerm":"Deep vein thrombosis", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA (12.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"22" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Catheter site haematoma", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA (12.0)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"4", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"22" } ] } },{ "OtherEventTerm":"Back pain", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventSourceVocabulary":"MedDRA (12.0)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"22" } ] } },{ "OtherEventTerm":"Non-cardiac chest pain", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA (12.0)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"22" } ] } },{ "OtherEventTerm":"Angina pectoris", "OtherEventOrganSystem":"Cardiac disorders", "OtherEventSourceVocabulary":"MedDRA (12.0)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"22" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes", "AgreementOtherDetails":"The Principal Investigator shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to Sponsor for review at least 45 days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation." }, "PointOfContact":{ "PointOfContactTitle":"Ruth Starzyk, PhD", "PointOfContactOrganization":"Boston Scientific", "PointOfContactEMail":"ruth.starzyk@bsci.com", "PointOfContactPhone":"508-683-6577" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000001241", "InterventionMeshTerm":"Aspirin" },{ "InterventionMeshId":"D000068338", "InterventionMeshTerm":"Everolimus" },{ "InterventionMeshId":"D000013988", "InterventionMeshTerm":"Ticlopidine" },{ "InterventionMeshId":"D000077144", "InterventionMeshTerm":"Clopidogrel" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000894", "InterventionAncestorTerm":"Anti-Inflammatory Agents, Non-Steroidal" },{ 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"ConditionBrowseLeafAsFound":"Coronary Artery Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M18089", "ConditionBrowseLeafName":"Myocardial Ischemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5132", "ConditionBrowseLeafName":"Coronary Disease", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9126", "ConditionBrowseLeafName":"Ischemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8002", "ConditionBrowseLeafName":"Heart Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3050", "ConditionBrowseLeafName":"Arteriosclerosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3046", "ConditionBrowseLeafName":"Arterial Occlusive Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }