{ "FullStudy":{ "Rank":217616, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519076", "OrgStudyIdInfo":{ "OrgStudyId":"PTI_CS001" }, "Organization":{ "OrgFullName":"Pulse Therapeutics", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Safety Evaluation of the Use of Magnetic-guided Iron Particles", "OfficialTitle":"A Feasibility Study: A Safety Evaluation of the Use of Magnetic-guided Iron Particles Administered to Patients Suffering Acute Ischemic Stroke and Treated With Tissue Plasminogen Activator (tPA)" }, "StatusModule":{ "StatusVerifiedDate":"December 2014", "OverallStatus":"Terminated", "WhyStopped":"Sponsor Request", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"July 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 8, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 10, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Pulse Therapeutics", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"This study is a prospective trial wherein each included subject will receive the experimental magnetically enhanced diffusion therapy. It will be conducted on a maximum of ten adult male or female patients who meet the inclusion and exclusion criteria and informed consent has been obtained. Subjects presenting in the emergency department with acute ischemic stroke and are eligible for tPA therapy may be considered for inclusion in the study.", "DetailedDescription":"This study is a prospective trial wherein each included subject will receive the experimental magnetically enhanced diffusion therapy. It will be conducted on a maximum of ten adult male or female patients who meet the inclusion and exclusion criteria and informed consent has been obtained. Subjects presenting in the emergency department with acute ischemic stroke and are eligible for tPA therapy may be considered for inclusion in the study.\n\nSubjects who meet the eligibility criteria will be treated with Magnetically Enhanced Diffusion (MED) concurrently with tPA infusion. Perfusion will be assessed using CTA/CTP at 2-4 hours upon completion of tPA infusion and using MRI at 24 hours upon completion of tPA infusion. Subjects are followed at 14 days, 30 days and 90 days post-treatment." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Ischemic Stroke" ] }, "KeywordList":{ "Keyword":[ "stroke" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"7", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED)", "InterventionDescription":"The PTI MED System is a magnetic-controlled infusion system which uses external energy (magnetic energy) to drive an agent (tPA) to the desired target (blood clot)." } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Safety: incidence and evaluation of any adverse effects associated with the investigational procedure compared with historical controls treated with tPA alone.", "PrimaryOutcomeDescription":"The primary measures of safety will be mortality at 3 months and symptomatic ICH within the first 24 hours post-treatment. All intracerebral hemorrhages (ICH) will be classified radiographically using the ECASS criteria. The proportion of subjects with Type II parenchymal intracerebral hematomas within the first 24 hours post-treatment and the incidence of any asymptomatic hemorrhage within the first 24 hours will also be compared.", "PrimaryOutcomeTimeFrame":"90 days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Brain Recanalization and perfusion", "SecondaryOutcomeDescription":"The degree of recanalization (partial and complete) and reperfusion will be assessed at 2-4 hours post-treatment using CT angiography, and at 24 +/- 6 hours post-treatment using MRI. TIMI Grade Flow of 2 or 3 will be considered \"responsive to treatment\".", "SecondaryOutcomeTimeFrame":"24 hours" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubject is between 18 and 80 years of age.\nSubject has moderate to large (NIHSS ≥ 10 and ≤24) ischemic stroke\nSubject has an intracranial arterial occlusion of the middle cerebral artery (MCA), anterior cerebral artery (ACA), internal carotid artery (ICA), posterior cerebral artery (PCA) or distal basilar artery confirmed by CT or MR angiography.\nSubject is eligible for initiation of intravenous tPA within three hours of stroke onset, where time of stroke onset is defined as the last time the patient was witnessed to be at baseline.\n\nExclusion Criteria:\n\nSubject has known sensitivity to iron or PEG products.\nSubject has recently (within 30 days) received iron replacement therapy.\nSubject has known or suspect liver function abnormality.\nSubject has known or suspect severe renal impairment.\nSubject has a high-density lesion on baseline CT scan consistent with hemorrhage of any degree.\nSubject has a significant mass on baseline CT consistent with midline shift.\nSubject has a large (greater than one-third of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan.\nSubject has evidence of intraparenchymal tumor on baseline CT scan.\nSubject experiences a seizure at the onset of stroke.\nSubject has known hemosiderosis or hemochromatosis.\nSubject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with MRI.\nSubject has a history of stroke within the last three months.\nSubject has a previous or existing intracranial hemorrhage, neoplasm, subarachnoid hemorrhage or arteriovenous malformation.\nSubject has experienced any active or recent (within 30 days) hemorrhage.\nSubject has systolic blood pressure > 185 mmHg or diastolic > 110 mmHg.\nSubject has presumed septic embolus or suspicion of bacterial endocarditis.\nSubject has presumed pericarditis including pericarditis after acute myocardial infarction.\nSubject is suspected to have an aortic dissection.\nSubject has recently (within 30 days) undergone surgery or biopsy of a parenchymal organ.\nSubject has recently (within 30 days) experienced trauma with internal injuries or ulcerative wounds.\nSubject has recently (within 90 days) experienced severe head trauma with loss of consciousness.\nSubject has known hereditary or acquired hemorrhage diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 1.7 or institutionally equivalent prothrombin time.\nSubject has a glucose level of < 50 mg/dl or >400 mg/dl, or a platelet count less than 100,000, or an Hct level less than 25.\nSubject has taken dabigatran within the last 48 hours or any new anticoagulant which cannot be monitored by traditional.\nSubject requires hemodialysis or peritoneal dialysis, or has a contraindication to angiogram.\nSubject has prolonged partial thromboplastin time (PTT) (in the case where heparin or a direct thrombin inhibitor has been administered within 48 hours).\nSubject has had a recent (within 7 days) lumbar puncture or arterial puncture at a non-compressible site.\nSubject has a pre-existing neurological or psychiatric disease that would confound evaluations.\nSubject is pregnant, nursing or intends to become pregnant during the trial period.\nSubject is currently enrolled in other potentially confounding research.\nSubject has any condition that, at the discretion of the investigator, would preclude participation in the trial.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"80 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Christopher Bladin, MD", "OverallOfficialAffiliation":"Eastern Health Services Box Hill Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Hunter New England", "LocationCity":"New Lambton", "LocationState":"New South Wales", "LocationCountry":"Australia" },{ "LocationFacility":"Eastern Health Services Box Hill Hospital", "LocationCity":"Box Hill", "LocationState":"Victoria", "LocationCountry":"Australia" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000003033", "InterventionMeshTerm":"Coal Tar" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000007641", "InterventionAncestorTerm":"Keratolytic Agents" },{ "InterventionAncestorId":"D000003879", "InterventionAncestorTerm":"Dermatologic Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M4846", "InterventionBrowseLeafName":"Coal Tar", "InterventionBrowseLeafAsFound":"Therapeutics", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M9250", "InterventionBrowseLeafName":"Keratolytic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M5657", "InterventionBrowseLeafName":"Dermatologic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Derm", "InterventionBrowseBranchName":"Dermatologic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000020521", "ConditionMeshTerm":"Stroke" },{ "ConditionMeshId":"D000007511", "ConditionMeshTerm":"Ischemia" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000002561", "ConditionAncestorTerm":"Cerebrovascular Disorders" },{ "ConditionAncestorId":"D000001927", "ConditionAncestorTerm":"Brain Diseases" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M20890", "ConditionBrowseLeafName":"Stroke", "ConditionBrowseLeafAsFound":"Stroke", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9126", "ConditionBrowseLeafName":"Ischemia", "ConditionBrowseLeafAsFound":"Ischemic", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4393", "ConditionBrowseLeafName":"Cerebrovascular Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3786", "ConditionBrowseLeafName":"Brain Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }