Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-09 @ 1:35 PM
Study NCT ID:
NCT03209804
Status:
COMPLETED
Last Update Posted:
2020-03-13
First Post:
2017-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002538', 'term': 'Intracranial Arteriovenous Malformations'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020785', 'term': 'Central Nervous System Vascular Malformations'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Traditional therapy group：traditional management of AVMs, such as unsimultaneous endovascular interventional embolisation, radiotherapy followed by microsurgical resection, will be conducted to patients involved in this group.\n\nHybrid operation group: A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously to patients in this group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 519}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2017-06-26', 'studyFirstSubmitQcDate': '2017-07-03', 'lastUpdatePostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Instant residual rate of AVMs', 'timeFrame': 'up to 1 week after operation', 'description': 'The instant post-operative residual rate of AVMs'}, {'measure': "3 months' residual rate of AVMs", 'timeFrame': 'the date of 3rd month after operation, ±1 week', 'description': "3 months' residual rate after AVM operation"}, {'measure': "6 months' residual rate of AVMs", 'timeFrame': 'the date of the 6th month after operation, ±1 week', 'description': "6 months' residual rate after AVM operation"}, {'measure': "1 year's residual rate of AVMs", 'timeFrame': 'the date of the 12th month after operation, ±1 week', 'description': "1 year's residual rate after AVM operation"}], 'secondaryOutcomes': [{'measure': 'Morbidity rate of post-operative complications', 'timeFrame': '7 days after operation', 'description': 'Include intracranial hemorrhage or infarction, infection of central neural system, infection of respiratory system, cranial nerve deficits, and other symptomatic complications'}, {'measure': 'Post-operative mortality rate', 'timeFrame': '48 hours after operation', 'description': 'operation related mortality'}, {'measure': 'Morbidity rate of neural functional deterioration-48 hours after operation', 'timeFrame': 'the assessing time points is 48 hours after operation', 'description': 'The score of modified Rankin Scale increases ≥2'}, {'measure': 'Morbidity rate of neural functional deterioration-1 week after operation', 'timeFrame': '1 week after operation', 'description': 'The score of modified Rankin Scale increases ≥2'}, {'measure': 'Morbidity rate of neural functional deterioration-3 months after operation', 'timeFrame': 'the 3rd month after operation, ±1 week', 'description': 'The score of modified Rankin Scale increases ≥2'}, {'measure': 'Morbidity rate of neural functional deterioration-6 months after operation', 'timeFrame': 'the 6th month after operation, ±1 week', 'description': 'The score of modified Rankin Scale increases ≥2'}, {'measure': 'Morbidity rate of neural functional deterioration-12 months after operation', 'timeFrame': 'the 12th month after operation, ±1 week', 'description': 'The score of modified Rankin Scale increases ≥2'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intracranial Arteriovenous Malformations'], 'conditions': ['Intracranial Arteriovenous Malformations']}, 'descriptionModule': {'briefSummary': 'To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.', 'detailedDescription': 'Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations(AVMs). Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.\n\nObjects: Patients with cerebral arteriovenous malformations, coincident with inclusion and exclusion criterion and admitted in participating organizations.\n\nMethods: Patients will be distributed into 2 groups, including traditional therapy group(control group) and hybrid operating group(trial group), and conduct with traditional neurosurgical management or one-stage hybrid operating management correspondingly. Residual rate of AVM is considered to be the primary observing indicator, and morbidity rate of post-operative complications, post-operative mortality rate, and morbidity rate of neural functional deterioration are secondary indicators.The information of operations will be recorded in detail as evidence of optimization of workflow and technical key knots.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newly ruptured AVM with stable hematoma, selective operation is practical;\n* with rupture history;\n* recurrent epilepsy, failed in AED management;\n* giant AVM with deterioration of neurological functions;\n* 1-4 grade AVM (Spetzler-Martin grading system) with no symptom and not located in eloquent area.\n\nExclusion Criteria:\n\n* \\>70 in age, with low rupture risk;\n* newly ruptured AVM with unstable hematoma, engaged in emergency operation;\n* ≥5 grade in Spetzler-Martin grading system;\n* AVM located in hypothalamus, brainstem, cerebellopontine angle;\n* cannot tolerant the operation;\n* patient or relative refuses to participate the trail.'}, 'identificationModule': {'nctId': 'NCT03209804', 'acronym': 'SMAVMHR', 'briefTitle': 'Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Science and Technology of the People´s Republic of China'}, 'officialTitle': 'Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room', 'orgStudyIdInfo': {'id': 'BJTTH-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Traditional neurosurgical techniques', 'description': 'Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines.', 'interventionNames': ['Procedure: hybrid operating techniques']}, {'type': 'EXPERIMENTAL', 'label': 'Hybrid operating techniques', 'description': 'A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously', 'interventionNames': ['Procedure: hybrid operating techniques']}], 'interventions': [{'name': 'hybrid operating techniques', 'type': 'PROCEDURE', 'otherNames': ['endovascular interventional embolisation', 'endovascular interventional balloon occlusion', 'microsurgical resection'], 'description': 'A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.', 'armGroupLabels': ['Hybrid operating techniques', 'Traditional neurosurgical techniques']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0086', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tiantan Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'General Hospital of PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100088', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Rocket Army General Hospital of PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Science and Technology of the People´s Republic of China', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Beijing Municipal Science & Technology Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'liuxingju', 'investigatorFullName': 'Shuo Wang', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}