Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-03-10 @ 11:32 PM
Study NCT ID:
NCT04988503
Status:
TERMINATED
Last Update Posted:
2025-07-25
First Post:
2021-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bare Platinum Coils Versus Second-generation Hydrocoils
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017542', 'term': 'Aneurysm, Ruptured'}, {'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D012421', 'term': 'Rupture'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'bare platinum coils group versus second-generation hydrogel coil group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'whyStopped': 'Due to HEC supply issues at participating centers and low enrollment rate among eligible patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2021-07-23', 'studyFirstSubmitQcDate': '2021-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'any recurrence rate after treatment', 'timeFrame': 'during 12 months after coil embolization', 'description': 'any recurrence rate at 12 months after coil embolization'}], 'secondaryOutcomes': [{'measure': 'rate of retreatment during 12 months follow-up period', 'timeFrame': 'rate of retreatment during 12 months follow-up period', 'description': 'rate of retreatment during 12 months follow-up period'}, {'measure': 'packing density (%) after coil embolization', 'timeFrame': 'packing density (%) after coil embolization', 'description': 'packing density (%) after coil embolization'}, {'measure': 'Procedural complication', 'timeFrame': 'during coil embolization', 'description': 'Procedural complication'}, {'measure': 'delayed cerebral ischemia during 12-month follow-up period', 'timeFrame': 'delayed cerebral ischemia during 12-month follow-up period', 'description': 'delayed cerebral ischemia during 12-month follow-up period'}, {'measure': 'good clinical outcome (mRS score ≤ 2) at 12-month follow-up period', 'timeFrame': 'good clinical outcome (mRS score ≤ 2) at 12-month follow-up period', 'description': 'good clinical outcome (mRS score ≤ 2) at 12-month follow-up period'}, {'measure': 'rate of ventriculoperitoneal shunt during 12-month follow-up period', 'timeFrame': 'rate of ventriculoperitoneal shunt during 12-month follow-up period', 'description': 'rate of ventriculoperitoneal shunt during 12-month follow-up period'}, {'measure': "coil's ease of manipulation", 'timeFrame': 'during coil embolization', 'description': "coil's ease of manipulation"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aneurysms', 'embolization', 'rupture'], 'conditions': ['Aneurysm, Ruptured', 'Intracranial Aneurysm']}, 'descriptionModule': {'briefSummary': 'Comparison of clinical and radiological outcomes between bare platinum coil group and second-generation hydrogel coils for treatment of ruptured intracranial aneurysms.', 'detailedDescription': 'The investigators aimed to analyze whether the use of second-generation hydrogel coils for the treatment of ruptured intracranial aneurysms improves clinical and angiographic outcomes compared with the use of bare platinum coils.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 year old or older\n* untreated ruptured intracranial aneurysms with an anatomy such that endovascular treatment with either bare platinum or second-generation hydrogel coils was considered feasible.\n* person who agreed to study\n\nExclusion Criteria:\n\n* contrast allgery (+)\n* combined other intracranial lesions (tumor, moyamoya disease, cerebral vascular diseases)\n* ineligible for coil embolization'}, 'identificationModule': {'nctId': 'NCT04988503', 'briefTitle': 'Bare Platinum Coils Versus Second-generation Hydrocoils', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Bare Platinum Coils Versus Second-generation Hydrocoils for the Endovascular Treatment of Ruptured Intracranial Aneurysms: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'B-2012/652-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Second-generation hydrogel coil group', 'description': 'Treatment using second-generation hydrogel coils (had to constitute \\> 50% of the total coil length) for ruptured cerebral aneurysms', 'interventionNames': ['Device: Coil embolization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bare platinum coil group', 'description': 'Treatment using bare metal coil only for ruptured cerebral aneurysms', 'interventionNames': ['Device: Coil embolization']}], 'interventions': [{'name': 'Coil embolization', 'type': 'DEVICE', 'description': 'coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils', 'armGroupLabels': ['Bare platinum coil group', 'Second-generation hydrogel coil group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30099', 'city': 'Sejong', 'state': 'Chungcheongnam-do', 'country': 'South Korea', 'facility': 'Chungnam National University Sejong Hospital'}, {'zip': '50612', 'city': 'Yangsan', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}, {'zip': '13620', 'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'O-Ki Kwon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, {'name': 'Chungnam National University Sejong Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}