{ "FullStudy":{ "Rank":217801, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516658", "OrgStudyIdInfo":{ "OrgStudyId":"TRIBRAIN1119" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"UMIN000006748", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"UMIN Japan" } ] }, "Organization":{ "OrgFullName":"Kobe City General Hospital", "OrgClass":"OTHER" }, "BriefTitle":"HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study", "OfficialTitle":"Efficacy of Hydrogel Coil on Endovascular Treatment for Intracranial Aneurysms; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial", "Acronym":"HYBRID" }, "StatusModule":{ "StatusVerifiedDate":"October 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"March 2018", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2019", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"November 29, 2011", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"October 14, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 16, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Nobuyuki Sakai", "ResponsiblePartyInvestigatorTitle":"Director of Neurosurgery", "ResponsiblePartyInvestigatorAffiliation":"Kobe City General Hospital" }, "LeadSponsor":{ "LeadSponsorName":"Kobe City General Hospital", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"HYBRID study is prospective randomized open label controlled multi center trial, to compare Hydrocoil and bare platinum coil for recanalization after endovascular treatment of intracranial aneurysms.", "DetailedDescription":"At least one Hydrocoil have to use in Hydrocoil arm, and only bare platinum coil have to use in Control arm.\n\nPrimary endpoint is recanalization within 1 year after embolization, and secondary endpoint are:\n\naneurysmal rupture within 1 year after embolization\nany event within 30 days after embolization\nrecanalization within 6 months after embolization\naneurysmal retreatment within 1 year after embolization\naneurysmal rupture and any death within 1 year after embolization\nany stroke within 1 year after embolization\nany stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization\nchange in aneurysmal occlusion\nany comlicaion within 1 year after embolization\n%length of Hydrocoil, maximum diameter of aneurysm, volume embolization ratio." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Intracranial Aneurysm", "Subarachnoid Hemorrhage" ] }, "KeywordList":{ "Keyword":[ "intracranial aneurysm", "endovascular therapy", "detachable coil", "recanalization" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"431", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Hydrogel coil group", "ArmGroupType":"Experimental", "ArmGroupDescription":"use Hydrogel Coil as much as be able to use", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Hydrogel coil" ] } },{ "ArmGroupLabel":"Bare platinum coil group", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"use only bare platinum coil", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Bare platinum coil" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Hydrogel coil", "InterventionDescription":"at least one Hydrogel coil have to use for embolization", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Hydrogel coil group" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Hydrocoil", "HydroSoft", "HydroFrame" ] } },{ "InterventionType":"Device", "InterventionName":"Bare platinum coil", "InterventionDescription":"only bare platinum coil have to use for embolization", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Bare platinum coil group" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "detachable coil", "GDC", "Microvention" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"recanalization within 1 year after embolization", "PrimaryOutcomeTimeFrame":"1 year" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"aneurysmal rupture within 1 year after embolization", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"any event within 30 days after embolization", "SecondaryOutcomeTimeFrame":"30 days" },{ "SecondaryOutcomeMeasure":"aneurysmal retreatment within 1 year after embolization", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"aneurysmal rupture and any death within 1 year after embolization", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"any stroke within 1 year after embolization", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"change in aneurysmal occlusion", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"any complicaion within 1 year after embolization", "SecondaryOutcomeTimeFrame":"1 year" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nsaccular intracranial aneurysm\nendovascular treatment scheduled within 60days after consent\n20-79 years old\nunruptured, chronic SAH or acurte SAH Grade 1-III\n7-20mm in size\n1 year follow up possibel\nindependent (mRS 0-2)\ndocument consent\n\nExclusion Criteria:\n\nprevious endovascular treated\nadditional aneurysm scheduled of endovascular treatment\npregnant\nineligible for study", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"20 Years", "MaximumAge":"79 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Nobuyuki Sakai, MD, DMSc", "OverallOfficialAffiliation":"Kobe City Medical Center General Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Nakamura Memorial Hospital", "LocationCity":"Sapporo", "LocationState":"Hokkaido", "LocationCountry":"Japan" },{ "LocationFacility":"Kobe City General Hospital", "LocationCity":"Kobe", "LocationState":"Hyogo", "LocationCountry":"Japan" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000013345", "ConditionMeshTerm":"Subarachnoid Hemorrhage" },{ "ConditionMeshId":"D000002532", "ConditionMeshTerm":"Intracranial Aneurysm" },{ "ConditionMeshId":"D000000783", "ConditionMeshTerm":"Aneurysm" },{ "ConditionMeshId":"D000006470", "ConditionMeshTerm":"Hemorrhage" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000020300", "ConditionAncestorTerm":"Intracranial Hemorrhages" },{ "ConditionAncestorId":"D000002561", "ConditionAncestorTerm":"Cerebrovascular Disorders" },{ "ConditionAncestorId":"D000001927", "ConditionAncestorTerm":"Brain Diseases" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000020765", "ConditionAncestorTerm":"Intracranial Arterial Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8139", "ConditionBrowseLeafName":"Hemorrhage", "ConditionBrowseLeafAsFound":"Hemorrhage", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14718", "ConditionBrowseLeafName":"Subarachnoid Hemorrhage", "ConditionBrowseLeafAsFound":"Subarachnoid Hemorrhage", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M2694", "ConditionBrowseLeafName":"Aneurysm", "ConditionBrowseLeafAsFound":"Aneurysm", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4364", "ConditionBrowseLeafName":"Intracranial Aneurysm", "ConditionBrowseLeafAsFound":"Intracranial Aneurysm", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M20697", "ConditionBrowseLeafName":"Intracranial Hemorrhages", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4393", "ConditionBrowseLeafName":"Cerebrovascular Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3786", "ConditionBrowseLeafName":"Brain Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M21105", "ConditionBrowseLeafName":"Intracranial Arterial Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" } ] } } } } } }