Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT01516658
Status:
COMPLETED
Last Update Posted:
2019-10-16
First Post:
2011-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 431}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-14', 'studyFirstSubmitDate': '2011-11-29', 'studyFirstSubmitQcDate': '2012-01-24', 'lastUpdatePostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recanalization within 1 year after embolization', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'aneurysmal rupture within 1 year after embolization', 'timeFrame': '1 year'}, {'measure': 'any event within 30 days after embolization', 'timeFrame': '30 days'}, {'measure': 'aneurysmal retreatment within 1 year after embolization', 'timeFrame': '1 year'}, {'measure': 'aneurysmal rupture and any death within 1 year after embolization', 'timeFrame': '1 year'}, {'measure': 'any stroke within 1 year after embolization', 'timeFrame': '1 year'}, {'measure': 'any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization', 'timeFrame': '1 year'}, {'measure': 'change in aneurysmal occlusion', 'timeFrame': '1 year'}, {'measure': 'any complicaion within 1 year after embolization', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intracranial aneurysm', 'endovascular therapy', 'detachable coil', 'recanalization'], 'conditions': ['Intracranial Aneurysm', 'Subarachnoid Hemorrhage']}, '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\n1. aneurysmal rupture within 1 year after embolization\n2. any event within 30 days after embolization\n3. recanalization within 6 months after embolization\n4. aneurysmal retreatment within 1 year after embolization\n5. aneurysmal rupture and any death within 1 year after embolization\n6. any stroke within 1 year after embolization\n7. any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization\n8. change in aneurysmal occlusion\n9. any comlicaion within 1 year after embolization\n10. %length of Hydrocoil, maximum diameter of aneurysm, volume embolization ratio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* saccular intracranial aneurysm\n* endovascular treatment scheduled within 60days after consent\n* 20-79 years old\n* unruptured, chronic SAH or acurte SAH Grade 1-III\n* 7-20mm in size\n* 1 year follow up possibel\n* independent (mRS 0-2)\n* document consent\n\nExclusion Criteria:\n\n* previous endovascular treated\n* additional aneurysm scheduled of endovascular treatment\n* pregnant\n* ineligible for study'}, 'identificationModule': {'nctId': 'NCT01516658', 'acronym': 'HYBRID', 'briefTitle': 'HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study', 'organization': {'class': 'OTHER', 'fullName': 'Kobe City General Hospital'}, 'officialTitle': 'Efficacy of Hydrogel Coil on Endovascular Treatment for Intracranial Aneurysms; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial', 'orgStudyIdInfo': {'id': 'TRIBRAIN1119'}, 'secondaryIdInfos': [{'id': 'UMIN000006748', 'type': 'OTHER', 'domain': 'UMIN Japan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydrogel coil group', 'description': 'use Hydrogel Coil as much as be able to use', 'interventionNames': ['Device: Hydrogel coil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bare platinum coil group', 'description': 'use only bare platinum coil', 'interventionNames': ['Device: Bare platinum coil']}], 'interventions': [{'name': 'Hydrogel coil', 'type': 'DEVICE', 'otherNames': ['Hydrocoil', 'HydroSoft', 'HydroFrame'], 'description': 'at least one Hydrogel coil have to use for embolization', 'armGroupLabels': ['Hydrogel coil group']}, {'name': 'Bare platinum coil', 'type': 'DEVICE', 'otherNames': ['detachable coil', 'GDC', 'Microvention'], 'description': 'only bare platinum coil have to use for embolization', 'armGroupLabels': ['Bare platinum coil group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Nakamura Memorial Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kobe City General Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}], 'overallOfficials': [{'name': 'Nobuyuki Sakai, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kobe City Medical Center General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kobe City General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Neurosurgery', 'investigatorFullName': 'Nobuyuki Sakai', 'investigatorAffiliation': 'Kobe City General Hospital'}}}}