{ "FullStudy":{ "Rank":217911, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515228", "OrgStudyIdInfo":{ "OrgStudyId":"CVRF2011-11" }, "Organization":{ "OrgFullName":"CardioVascular Research Foundation, Korea", "OrgClass":"OTHER" }, "BriefTitle":"Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)", "OfficialTitle":"Randomized Comparison of Dual Drug-Eluting Cilotax Stent and Everolimus -Eluting Stent Implantation for DE Novo Coronary Artery DisEase in Patients With DIABETES Mellitus" }, "StatusModule":{ "StatusVerifiedDate":"January 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 8, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 9, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor-Investigator", "ResponsiblePartyInvestigatorFullName":"CHEOL WHAN LEE, MD, PhD.", "ResponsiblePartyInvestigatorTitle":"MD", "ResponsiblePartyInvestigatorAffiliation":"CardioVascular Research Foundation, Korea" }, "LeadSponsor":{ "LeadSponsorName":"CHEOL WHAN LEE, MD, PhD.", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"CardioVascular Research Foundation, Korea", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients.", "DetailedDescription":"Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Cilotax stent vs. b) Xience Prime stent. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Coronary Artery Disease" ] }, "KeywordList":{ "Keyword":[ "requiring drug eluting stents" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"291", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Xience Prime stent", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"everolimus eluting stent", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Cilotax stent" ] } },{ "ArmGroupLabel":"Cilotax stent", "ArmGroupType":"Experimental", "ArmGroupDescription":"paclitaxel with cilostazol dual drug eluting stent", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Xience Prime" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Xience Prime", "InterventionDescription":"everolimus-eluting stent implantation", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Cilotax stent" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "everolimus-eluting stent" ] } },{ "InterventionType":"Device", "InterventionName":"Cilotax stent", "InterventionDescription":"paclitaxel with cilostazol dual drug eluting stent implantation", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Xience Prime stent" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "paclitaxel with cilostazol dual drug eluting stent" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"In-segment late luminal loss", "PrimaryOutcomeTimeFrame":"at 9 month angiographic follow-up" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"All Death", "SecondaryOutcomeTimeFrame":"12 months" },{ "SecondaryOutcomeMeasure":"Cardiac death", "SecondaryOutcomeTimeFrame":"12 months" },{ "SecondaryOutcomeMeasure":"Myocardial infarction", "SecondaryOutcomeTimeFrame":"12 months" },{ "SecondaryOutcomeMeasure":"Target vessel revascularization (ischemia-driven)", "SecondaryOutcomeTimeFrame":"12 months" },{ "SecondaryOutcomeMeasure":"Target lesion revascularization (ischemia-driven)", "SecondaryOutcomeTimeFrame":"12 months" },{ "SecondaryOutcomeMeasure":"Stent thrombosis (by ARC definition)", "SecondaryOutcomeTimeFrame":"12 months" },{ "SecondaryOutcomeMeasure":"Binary restenosis in both in-stent and in-segment", "SecondaryOutcomeTimeFrame":"at 9 month angiographic follow-up" },{ "SecondaryOutcomeMeasure":"Angiographic pattern of restenosis", "SecondaryOutcomeTimeFrame":"at 9 month angiographic follow-up" },{ "SecondaryOutcomeMeasure":"Procedural success", "SecondaryOutcomeDescription":"achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay", "SecondaryOutcomeTimeFrame":"At discharge from the index hospitalization, an expected average of 3 days." },{ "SecondaryOutcomeMeasure":"All Death", "SecondaryOutcomeTimeFrame":"1 month" },{ "SecondaryOutcomeMeasure":"All Death", "SecondaryOutcomeTimeFrame":"4 months" },{ "SecondaryOutcomeMeasure":"All Death", "SecondaryOutcomeTimeFrame":"9 months" },{ "SecondaryOutcomeMeasure":"Cardiac death", "SecondaryOutcomeTimeFrame":"1 month" },{ "SecondaryOutcomeMeasure":"Cardiac death", "SecondaryOutcomeTimeFrame":"4 months" },{ "SecondaryOutcomeMeasure":"Cardiac death", "SecondaryOutcomeTimeFrame":"9 months" },{ "SecondaryOutcomeMeasure":"Myocardial infarction", "SecondaryOutcomeTimeFrame":"1 month" },{ "SecondaryOutcomeMeasure":"Myocardial infarction", "SecondaryOutcomeTimeFrame":"4 months" },{ "SecondaryOutcomeMeasure":"Myocardial infarction", "SecondaryOutcomeTimeFrame":"9 months" },{ "SecondaryOutcomeMeasure":"Target vessel revascularization (ischemia-driven)", "SecondaryOutcomeTimeFrame":"1 month" },{ "SecondaryOutcomeMeasure":"Target vessel revascularization (ischemia-driven)", "SecondaryOutcomeTimeFrame":"4 months" },{ "SecondaryOutcomeMeasure":"Target vessel revascularization (ischemia-driven)", "SecondaryOutcomeTimeFrame":"9 months" },{ "SecondaryOutcomeMeasure":"Target lesion revascularization (ischemia-driven)", "SecondaryOutcomeTimeFrame":"1 month" },{ "SecondaryOutcomeMeasure":"Target lesion revascularization (ischemia-driven)", "SecondaryOutcomeTimeFrame":"4 months" },{ "SecondaryOutcomeMeasure":"Target lesion revascularization (ischemia-driven)", "SecondaryOutcomeTimeFrame":"9 months" },{ "SecondaryOutcomeMeasure":"Stent thrombosis (by ARC definition)", "SecondaryOutcomeTimeFrame":"1 month" },{ "SecondaryOutcomeMeasure":"Stent thrombosis (by ARC definition)", "SecondaryOutcomeTimeFrame":"4 months" },{ "SecondaryOutcomeMeasure":"Stent thrombosis (by ARC definition)", "SecondaryOutcomeTimeFrame":"9 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nClinical:\n\nDiabetic patients with active treatment (oral agent or insulin)\nPatients with angina and documented ischemia or patients with documented silent ischemia\nPatients who are eligible for intracoronary stenting\nAge > 20 years, < 75 years\n\nAngiographic:\n\nDe novo lesion\nPercent diameter stenosis ≥ 50%\nReference vessel size ≥ 2.5 mm by visual estimation\n\nExclusion Criteria:\n\nHistory of bleeding diathesis or coagulopathy\nPregnant state\nKnown hypersensitivity or contra-indication to contrast agent and heparin\nLimited life-expectancy (less than 1 year)\nST-elevation acute myocardial infraction requiring primary stenting\nCharacteristics of lesion: left main disease, in-stent restenosis, graft vessels\nHematological disease (Neutropenia < 3000/mm3), Thrombocytopenia < 100,000/mm3)\nHepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3times normal\nRenal dysfunction, creatinine ≥ 2.0mg/dL\nContraindication to aspirin, clopidogrel or cilostazol\nContraindication to Paclitaxel or everolimus\nLeft ventricular ejection fraction < 30%\nPatients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period\nNon-cardiac co-morbid conditions are present with life expectancy < 1 year or that may result in protocol non-compliance (per site investigator's medical judgment for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"21 Years", "MaximumAge":"74 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Cheol-Whan Lee, MD", "OverallOfficialAffiliation":"Asan Medical Center", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Soon Chun Hyang University Hospital Cheonan", "LocationCity":"Cheonan", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Daegu Catholic University Medical Center", "LocationCity":"Daegu", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Keimyung University Dongsan Medical Center", "LocationCity":"Daegu", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Chungnam National University Hospital", "LocationCity":"Daejeon", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"The Catholic University of Korea, Daejeon ST. Mary's Hospital", "LocationCity":"Daejeon", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Gangneung Asan Hospital", "LocationCity":"Gangneung", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Inje University Pusan Paik Hospital", "LocationCity":"Pusan", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Asan Medical Center", "LocationCity":"Seoul", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Ulsan University Hospital", "LocationCity":"Ulsan", "LocationCountry":"Korea, Republic of" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000017239", "InterventionMeshTerm":"Paclitaxel" },{ "InterventionMeshId":"D000068338", "InterventionMeshTerm":"Everolimus" },{ "InterventionMeshId":"D000077407", "InterventionMeshTerm":"Cilostazol" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000972", "InterventionAncestorTerm":"Antineoplastic Agents, Phytogenic" },{ "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000050257", "InterventionAncestorTerm":"Tubulin Modulators" },{ "InterventionAncestorId":"D000050256", "InterventionAncestorTerm":"Antimitotic Agents" },{ "InterventionAncestorId":"D000050258", "InterventionAncestorTerm":"Mitosis Modulators" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000007166", "InterventionAncestorTerm":"Immunosuppressive Agents" },{ "InterventionAncestorId":"D000007155", "InterventionAncestorTerm":"Immunologic Factors" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000001993", "InterventionAncestorTerm":"Bronchodilator Agents" },{ "InterventionAncestorId":"D000001337", "InterventionAncestorTerm":"Autonomic Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000018927", "InterventionAncestorTerm":"Anti-Asthmatic Agents" },{ "InterventionAncestorId":"D000019141", "InterventionAncestorTerm":"Respiratory System Agents" },{ "InterventionAncestorId":"D000005343", "InterventionAncestorTerm":"Fibrinolytic Agents" },{ "InterventionAncestorId":"D000050299", "InterventionAncestorTerm":"Fibrin Modulating Agents" },{ "InterventionAncestorId":"D000010975", "InterventionAncestorTerm":"Platelet Aggregation Inhibitors" },{ "InterventionAncestorId":"D000014665", "InterventionAncestorTerm":"Vasodilator Agents" },{ "InterventionAncestorId":"D000018696", "InterventionAncestorTerm":"Neuroprotective Agents" },{ "InterventionAncestorId":"D000020011", "InterventionAncestorTerm":"Protective Agents" },{ "InterventionAncestorId":"D000058987", "InterventionAncestorTerm":"Phosphodiesterase 3 Inhibitors" },{ "InterventionAncestorId":"D000010726", "InterventionAncestorTerm":"Phosphodiesterase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M18120", "InterventionBrowseLeafName":"Paclitaxel", "InterventionBrowseLeafAsFound":"Paclitaxel", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M255", "InterventionBrowseLeafName":"Everolimus", "InterventionBrowseLeafAsFound":"Everolimus", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M231", "InterventionBrowseLeafName":"Albumin-Bound Paclitaxel", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M1788", "InterventionBrowseLeafName":"Cilostazol", "InterventionBrowseLeafAsFound":"Cilostazol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M24784", "InterventionBrowseLeafName":"Tubulin Modulators", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24783", "InterventionBrowseLeafName":"Antimitotic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8795", "InterventionBrowseLeafName":"Immunosuppressive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8784", "InterventionBrowseLeafName":"Immunologic Factors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3851", "InterventionBrowseLeafName":"Bronchodilator Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19547", "InterventionBrowseLeafName":"Anti-Asthmatic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19721", "InterventionBrowseLeafName":"Respiratory System Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7056", "InterventionBrowseLeafName":"Fibrinolytic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M12448", "InterventionBrowseLeafName":"Platelet Aggregation Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15995", "InterventionBrowseLeafName":"Vasodilator Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19357", "InterventionBrowseLeafName":"Neuroprotective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M20453", "InterventionBrowseLeafName":"Protective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M27920", "InterventionBrowseLeafName":"Phosphodiesterase 3 Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M12212", "InterventionBrowseLeafName":"Phosphodiesterase Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"FiAg", "InterventionBrowseBranchName":"Fibrinolytic Agents" },{ "InterventionBrowseBranchAbbrev":"VaDiAg", "InterventionBrowseBranchName":"Vasodilator Agents" },{ "InterventionBrowseBranchAbbrev":"NeuroAg", "InterventionBrowseBranchName":"Neuroprotective Agents" },{ "InterventionBrowseBranchAbbrev":"PlAggInh", "InterventionBrowseBranchName":"Platelet Aggregation Inhibitors" },{ "InterventionBrowseBranchAbbrev":"Resp", "InterventionBrowseBranchName":"Respiratory System Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003324", "ConditionMeshTerm":"Coronary Artery Disease" },{ "ConditionMeshId":"D000017202", "ConditionMeshTerm":"Myocardial Ischemia" },{ "ConditionMeshId":"D000003327", "ConditionMeshTerm":"Coronary Disease" },{ "ConditionMeshId":"D000003920", "ConditionMeshTerm":"Diabetes Mellitus" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000044882", "ConditionAncestorTerm":"Glucose Metabolism Disorders" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" },{ "ConditionAncestorId":"D000004700", "ConditionAncestorTerm":"Endocrine System Diseases" },{ "ConditionAncestorId":"D000006331", "ConditionAncestorTerm":"Heart Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000001161", "ConditionAncestorTerm":"Arteriosclerosis" },{ "ConditionAncestorId":"D000001157", "ConditionAncestorTerm":"Arterial Occlusive Diseases" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafAsFound":"Diabetes Mellitus", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5129", "ConditionBrowseLeafName":"Coronary Artery Disease", "ConditionBrowseLeafAsFound":"Coronary Artery Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M18089", "ConditionBrowseLeafName":"Myocardial Ischemia", "ConditionBrowseLeafAsFound":"Coronary Artery Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5132", "ConditionBrowseLeafName":"Coronary Disease", "ConditionBrowseLeafAsFound":"Coronary Artery Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9126", "ConditionBrowseLeafName":"Ischemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10222", "ConditionBrowseLeafName":"Metabolic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M23990", "ConditionBrowseLeafName":"Glucose Metabolism Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6445", "ConditionBrowseLeafName":"Endocrine System Diseases", "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":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }