Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT02982135
Status:
UNKNOWN
Last Update Posted:
2016-12-05
First Post:
2016-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009072', 'term': 'Moyamoya Disease'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery 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': 'D002539', 'term': 'Cerebral Arterial Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-02', 'studyFirstSubmitDate': '2016-11-20', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rebleeding events', 'timeFrame': '5-10 years'}], 'secondaryOutcomes': [{'measure': 'ischemic events', 'timeFrame': '5-10 years'}, {'measure': 'postoperative compilications', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hemorrhagic moyamoya disease', 'bypass', 'indirect bypass'], 'conditions': ['Moyamoya Disease']}, 'descriptionModule': {'briefSummary': 'The investigators conducted a prospective multi-center study assessing the effect of direct bypass and indrect bypass in treatment of hemorrhagic moyamoya disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. cerebral digital subtraction contrast angiography (DSA) revealed severe stenosis or occlusion of the distal internal carotid or proximal middle and anterior cerebral arteries with prominent lenticulostriate "moyamoya collaterals"\n2. patients had experienced at least one intracranial hemorrhage which was verified by computed tomography (CT) scanning, magnetic resonance imaging MRI), or lumbar puncture.\n3. Patients requiring surgery\n\nExclusion Criteria:\n\n1. Patient whose initial onset was marked by ischemia but subsequently suffered from intracranial hemorrhage\n2. patients refused to participate in the study'}, 'identificationModule': {'nctId': 'NCT02982135', 'briefTitle': 'Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Science and Technology of the People´s Republic of China'}, 'officialTitle': 'Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease:a Prospective Multi-center Cohort Study', 'orgStudyIdInfo': {'id': 'BJTTH-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'group 1 direct bypass', 'description': 'direct bypass : patients recieve direct bypass treatment', 'interventionNames': ['Other: bypass surgery and indrect bypass surgery']}, {'type': 'OTHER', 'label': 'group 2 indirect bypass', 'description': 'indirect bypass: patients recieve indirect bypass treatment', 'interventionNames': ['Other: bypass surgery and indrect bypass surgery']}], 'interventions': [{'name': 'bypass surgery and indrect bypass surgery', 'type': 'OTHER', 'description': 'bypass surgery ： patients recieved STA-MCA bypass indrect bypass surgery：patients recieved EDAS or mutiple bur holes', 'armGroupLabels': ['group 1 direct bypass', 'group 2 indirect bypass']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0086', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'liu xingju, MD', 'role': 'CONTACT', 'email': 'liuxingju006@163.com', 'phone': '008615011476305'}], 'facility': 'Beijing Tiantan Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'liuxingju', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'liuxingju', 'investigatorAffiliation': 'Ministry of Science and Technology of the People´s Republic of China'}}}}