Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-02 @ 6:41 PM
Study NCT ID:
NCT00537134
Status:
TERMINATED
Last Update Posted:
2022-12-30
First Post:
2007-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial on Endovascular Aneurysm Management
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}], '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004621', 'term': 'Embolization, Therapeutic'}], 'ancestors': [{'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D060205', 'term': 'Therapeutic Occlusion'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ruby.klink.chum@ssss.gouv.qc.ca', 'phone': '(514) 890-8000', 'title': 'Ruby Klink', 'phoneExt': '27235', 'organization': "Centre Hospitalier de l'Université de Montréal (CHUM)"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'No conclusions can be drawn from the reported results because the study, projected to follow patients for 10 years was terminated by the funding agency after 3 years'}}, 'adverseEventsModule': {'timeFrame': 'The number of patients in each period of time over which Adverse event data was collected is variable, because the study was terminated while patients were at variable points through their expected follow-up period. For example, only 52/80 participants were evaluated at 1 month before the study was terminated; at each subsequent time point, fewer participants were evaluated. - 3 years: 2 patients - 2 years: 11 patients - 1 year: 25 patients - 6 months: 41 patients - 1 month: 52 patients', 'description': 'The definition of adverse event does not differ from the ClinicalTrials.gov definition', 'eventGroups': [{'id': 'EG000', 'title': 'Conservative', 'description': 'Conservative management (watchful observation)', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 2, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Endovascular', 'description': 'Endovascular treatment\n\nEmbolization, coiling: Endovascular embolization with platinum coils', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 3, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'arm hematoma', 'notes': 'hematoma resulting from arm arterial line complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Disease or Treatment-related Morbidity and Mortality.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conservative', 'description': 'Conservative management (watchful observation)\n\nInclusion criteria:\n\n1. At least one documented subarachnoid aneurysm, never ruptured\n2. Patient aged 18 or older\n3. Life expectancy more than 10 years\n\nExclusion crieria:\n\n1. Patients with recent (less than 3 months) intracranial haemorrhage\n2. Lesion characteristics unsuitable for endovascular treatment\n3. Patients with a single extradural aneurysm\n4. Aneurysms \\<3mm or giant aneurysms (≥25mm)\n5. Patients with a poor outcome (Rankin scale ≥3) after the rupture, surgical or endovascular treatment of another aneurysm\n6. Patients with incompletely treated aneurysms that have previously ruptured\n7. Patients with associated arteriovenous malformations\n8. Patients with new severe progressive symptoms in relationship with the aneurysm (sudden onset, severe persisting headaches suggestive of impending rupture, third-nerve palsy, mass-effect)\n9. Patients with previous intracranial haemorrhage from unknown aetiology\n10. Patients with multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management\n11. Patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium\n12. Pregnant patients\n13. Patients unable to give informed consent'}, {'id': 'OG001', 'title': 'Endovascular', 'description': 'Endovascular treatment\n\nEmbolization, coiling: Endovascular embolization with platinum coils\n\nSame population as Conservative management'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year after treatment or observation', 'description': 'Morbidity or mortality is evaluated using the modified Rankin Scale (mRS) which goes from 0 to 6, with 0 for no symptoms at all, and 6 for Mortality. The scores were attributed using a structured interview process.\n\na "Good" Primary Outcome was categorized from mRS scores of 0, 1, or 2. a "Bad" Primary Outcome was categorized from mRS scores of 3, 4, 5 or 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Hemorrhage in Conservative Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conservative', 'description': 'Conservative management (watchful observation)'}, {'id': 'OG001', 'title': 'Endovascular', 'description': 'Endovascular treatment\n\nEmbolization, coiling: Endovascular embolization with platinum coils'}], 'timeFrame': 'At 5 and 10 years', 'description': 'To better define the natural history of unruptured aneurysms eligible for endovascular treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients available for outcome measure at 5 years because study was terminated'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hemorrhage in Endovascular Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conservative', 'description': 'Conservative management (watchful observation)'}, {'id': 'OG001', 'title': 'Endovascular', 'description': 'Endovascular treatment\n\nEmbolization, coiling: Endovascular embolization with platinum coils'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 1 year', 'description': 'Number of participants experiencing a hemorrhagic event despite successful treatment.\n\nThis outcome measure gives an estimate of risk of rupture despite treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Each Score of the Modified Rankin Scale in Endovascular Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conservative', 'description': 'Conservative management (watchful observation)'}, {'id': 'OG001', 'title': 'Endovascular', 'description': 'Endovascular treatment\n\nEmbolization, coiling: Endovascular embolization with platinum coils'}], 'classes': [{'categories': [{'title': 'mRS is 0', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'mRS is 1', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'mRS is 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 1 year', 'description': 'The modified Rankin Scale (mRS) goes from 0 to 6, with 0 for no symptoms at all, and 6 for Mortality. The scores were attributed using a structured interview process.\n\nThe number of participants having in each score is given.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Rankin Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conservative', 'description': 'Conservative management (watchful observation)'}, {'id': 'OG001', 'title': 'Endovascular', 'description': 'Endovascular treatment\n\nEmbolization, coiling: Endovascular embolization with platinum coils'}], 'timeFrame': 'At 10 years', 'description': 'To compare overall Morbidity/Mortality of the 2 groups', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients available for outcome measure at 10 years because study was terminated'}, {'type': 'SECONDARY', 'title': 'Measures on 36-Item Short-Form Health Survey (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conservative', 'description': 'Conservative management (watchful observation)'}, {'id': 'OG001', 'title': 'Endovascular', 'description': 'Endovascular treatment\n\nEmbolization, coiling: Endovascular embolization with platinum coils'}], 'timeFrame': 'At 5 and 10 years', 'description': 'To compare the quality of life and anxiety levels of surviving patients of the 2 groups according to the SF-36 questionnaire minimum is 0 (maximum disability) maximum is 100 (No disability)', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients available for outcome measure at 5 and 10 years because study was terminated'}, {'type': 'SECONDARY', 'title': 'Occlusion State in the Endovascular Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conservative', 'description': 'Conservative management (watchful observation)'}, {'id': 'OG001', 'title': 'Endovascular', 'description': 'Endovascular treatment\n\nEmbolization, coiling: Endovascular embolization with platinum coils'}], 'timeFrame': 'At 5 and 10 years', 'description': 'To determine the rate of occlusion of aneurysms treated by coiling in an effort to estimate longer-term efficacy.', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients available for outcome measure at 5 years because study was terminated'}, {'type': 'SECONDARY', 'title': 'Occlusion State of the Aneurysm in the Conservative Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conservative', 'description': 'Conservative management (watchful observation)'}, {'id': 'OG001', 'title': 'Endovascular', 'description': 'Endovascular treatment\n\nEmbolization, coiling: Endovascular embolization with platinum coils'}], 'timeFrame': 'At 5 and 10 years', 'description': 'To determine the rate of aneurysmal growth in the conservative group in surviving patients.', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients available for outcome measure at 5 years because study was terminated'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a "Bad" Cognitive Function Evaluated According to the Montreal Cognitive Assessment Scale (MoCA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conservative', 'description': 'Conservative management (watchful observation)'}, {'id': 'OG001', 'title': 'Endovascular', 'description': 'Endovascular treatment\n\nEmbolization, coiling: Endovascular embolization with platinum coils'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'Score is 26 or lower', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Score is higher than 26', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '1 year', 'categories': [{'title': 'Score is 26 or lower', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Score is higher than 26', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 1 year, 5 and 10 years', 'description': 'To verify cognitive functions using the MoCA in all patients before and 6 months after treatment in a consecutive sample of 100 patients of both groups.\n\nMinimum value on the MoCA is 0 (maximum cognitive decline) Maximum value on the MoCA is 30 (no cognitive decline) A score higher than 26 was categorized as "good" cognitive condition A score of 26 or lower was categorized as "bad" cognitive conditionn', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with MoCa scores at Baseline and 1 year'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Endovascular', 'description': 'Endovascular treatment by coil embolization\n\nEmbolization, coiling: Endovascular embolization with platinum coils'}, {'id': 'FG001', 'title': 'Conservative', 'description': 'Conservative management (watchful observation)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants are recruited when seen in clinic either for neurological symptoms or when aneurysm is an incidental finding', 'preAssignmentDetails': 'there are no pre-assignment procedures before assignment to groups'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Conservative', 'description': 'Conservative management (watchful observation)\n\nInclusion criteria:\n\n1. At least one documented subarachnoid aneurysm, never ruptured\n2. Patient aged 18 or older\n3. Life expectancy more than 10 years\n\nExclusion crieria:\n\n1. Patients with recent (less than 3 months) intracranial haemorrhage\n2. Lesion characteristics unsuitable for endovascular treatment\n3. Patients with a single extradural aneurysm\n4. Aneurysms \\<3mm or giant aneurysms (≥25mm)\n5. Patients with a poor outcome (Rankin scale ≥3) after the rupture, surgical or endovascular treatment of another aneurysm\n6. Patients with incompletely treated aneurysms that have previously ruptured\n7. Patients with associated arteriovenous malformations\n8. Patients with new severe progressive symptoms in relationship with the aneurysm (sudden onset, severe persisting headaches suggestive of impending rupture, third-nerve palsy, mass-effect)\n9. Patients with previous intracranial haemorrhage from unknown aetiology\n10. Patients with multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management\n11. Patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium\n12. Pregnant patients\n13. Patients unable to give informed consent'}, {'id': 'BG001', 'title': 'Endovascular', 'description': 'Endovascular treatment\n\nEmbolization, coiling: Endovascular embolization with platinum coils\n\nSame population as Conservative management'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2007-03-03', 'size': 681320, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-28T10:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': 'The CIHR Financial support was withdrawn because of insufficient recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-06', 'studyFirstSubmitDate': '2007-09-26', 'resultsFirstSubmitDate': '2022-08-09', 'studyFirstSubmitQcDate': '2007-09-27', 'lastUpdatePostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-06', 'studyFirstPostDateStruct': {'date': '2007-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Disease or Treatment-related Morbidity and Mortality.', 'timeFrame': '1 year after treatment or observation', 'description': 'Morbidity or mortality is evaluated using the modified Rankin Scale (mRS) which goes from 0 to 6, with 0 for no symptoms at all, and 6 for Mortality. The scores were attributed using a structured interview process.\n\na "Good" Primary Outcome was categorized from mRS scores of 0, 1, or 2. a "Bad" Primary Outcome was categorized from mRS scores of 3, 4, 5 or 6.'}], 'secondaryOutcomes': [{'measure': 'Rate of Hemorrhage in Conservative Group', 'timeFrame': 'At 5 and 10 years', 'description': 'To better define the natural history of unruptured aneurysms eligible for endovascular treatment.'}, {'measure': 'Number of Participants With Hemorrhage in Endovascular Group', 'timeFrame': 'At 1 year', 'description': 'Number of participants experiencing a hemorrhagic event despite successful treatment.\n\nThis outcome measure gives an estimate of risk of rupture despite treatment'}, {'measure': 'Number of Participants in Each Score of the Modified Rankin Scale in Endovascular Group', 'timeFrame': 'At 1 year', 'description': 'The modified Rankin Scale (mRS) goes from 0 to 6, with 0 for no symptoms at all, and 6 for Mortality. The scores were attributed using a structured interview process.\n\nThe number of participants having in each score is given.'}, {'measure': 'Modified Rankin Score', 'timeFrame': 'At 10 years', 'description': 'To compare overall Morbidity/Mortality of the 2 groups'}, {'measure': 'Measures on 36-Item Short-Form Health Survey (SF-36)', 'timeFrame': 'At 5 and 10 years', 'description': 'To compare the quality of life and anxiety levels of surviving patients of the 2 groups according to the SF-36 questionnaire minimum is 0 (maximum disability) maximum is 100 (No disability)'}, {'measure': 'Occlusion State in the Endovascular Group', 'timeFrame': 'At 5 and 10 years', 'description': 'To determine the rate of occlusion of aneurysms treated by coiling in an effort to estimate longer-term efficacy.'}, {'measure': 'Occlusion State of the Aneurysm in the Conservative Group', 'timeFrame': 'At 5 and 10 years', 'description': 'To determine the rate of aneurysmal growth in the conservative group in surviving patients.'}, {'measure': 'Number of Participants With a "Bad" Cognitive Function Evaluated According to the Montreal Cognitive Assessment Scale (MoCA)', 'timeFrame': 'Baseline, 1 year, 5 and 10 years', 'description': 'To verify cognitive functions using the MoCA in all patients before and 6 months after treatment in a consecutive sample of 100 patients of both groups.\n\nMinimum value on the MoCA is 0 (maximum cognitive decline) Maximum value on the MoCA is 30 (no cognitive decline) A score higher than 26 was categorized as "good" cognitive condition A score of 26 or lower was categorized as "bad" cognitive conditionn'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aneurysm', 'Brain', 'Unruptured', 'observation', 'treatment', 'Endovascular'], 'conditions': ['Brain Aneurysm']}, 'referencesModule': {'references': [{'pmid': '17316800', 'type': 'BACKGROUND', 'citation': 'Raymond J, Meder JF, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; Trial on Endovascular Aneurysm Management (TEAM) collaborative group. Trial on endovascular treatment of unruptured aneurysms (TEAM): study monitoring and rationale for trial interruption or continuation. J Neuroradiol. 2007 Mar;34(1):33-41. doi: 10.1016/j.neurad.2007.01.011.'}, {'pmid': '17041525', 'type': 'BACKGROUND', 'citation': 'Raymond J, Meder JF, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; Trial On Endovascular Aneurysm Management Team Collaborative Group. Unruptured intracranial aneurysms: the unreliability of clinical judgment, the necessity for evidence, and reasons to participate in a randomized trial. J Neuroradiol. 2006 Oct;33(4):211-9. doi: 10.1016/s0150-9861(06)77266-2. No abstract available.'}, {'pmid': '16484380', 'type': 'BACKGROUND', 'citation': 'Raymond J, Guilbert F, Weill A, Roy D. Unruptured intracranial aneurysms: a call for a randomized clinical trial. AJNR Am J Neuroradiol. 2006 Feb;27(2):242-3. No abstract available.'}, {'pmid': '12775880', 'type': 'BACKGROUND', 'citation': 'Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A, Lamoureux J, Chagnon M, Roy D. Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke. 2003 Jun;34(6):1398-403. doi: 10.1161/01.STR.0000073841.88563.E9. Epub 2003 May 29.'}, {'pmid': '20587222', 'type': 'BACKGROUND', 'citation': 'Raymond J, Chagnon M, Collet JP, Guilbert F, Weill A, Roy D. A randomized trial on the safety and efficacy of endovascular treatment of unruptured intracranial aneurysms is feasible. Interv Neuroradiol. 2004 Jun 29;10(2):103-12. doi: 10.1177/159101990401000202. Epub 2004 Oct 22.'}, {'pmid': '18631395', 'type': 'BACKGROUND', 'citation': 'Raymond J, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; TEAM Collaborative Group. The TEAM trial: safety and efficacy of endovascular treatment of unruptured intracranial aneurysms in the prevention of aneurysmal hemorrhages: a randomized comparison with indefinite deferral of treatment in 2002 patients followed for 10 years. Trials. 2008 Jul 16;9:43. doi: 10.1186/1745-6215-9-43.'}, {'pmid': '21330400', 'type': 'DERIVED', 'citation': 'Naggara O, Raymond J, Guilbert F, Roy D, Weill A, Altman DG. Analysis by categorizing or dichotomizing continuous variables is inadvisable: an example from the natural history of unruptured aneurysms. AJNR Am J Neuroradiol. 2011 Mar;32(3):437-40. doi: 10.3174/ajnr.A2425. Epub 2011 Feb 17.'}, {'pmid': '19165956', 'type': 'DERIVED', 'citation': 'Raymond J. Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009 Feb;22(1):96-102. doi: 10.1097/wco.0b013e32831fee91.'}]}, 'descriptionModule': {'briefSummary': 'The management of patients with unruptured aneurysms is controversial. Patients with unruptured aneurysms may suffer intracranial hemorrhage, but the incidence of this event is still debated. Endovascular treatment can prevent rupture, but involves immediate risks; furthermore, successful treatment does not eliminate all risks. A randomized trial may be the best way to demonstrate the potential benefits of endovascular over conservative management of unruptured aneurysms.', 'detailedDescription': 'This study is designed as a pragmatic trial. All candidates for endovascular treatment of one or more unruptured intracranial aneurysms will be offered to participate. Unruptured aneurysms may be recently discovered or prevalent. If they accept, subjects will be randomized to one of the two arms of the trial: Conservative management (Observation) or Endovascular treatment.\n\nBoth groups will be advised to obtain medical treatment for hypertension if necessary and will receive counselling for behavioural risk factor modelling (smoking or excessive drinking) when indicated. A non-invasive (MRA or CTA) or catheter angiogram and a baseline CT-scan or MRI of the brain are required to enter the study. These studies should demonstrate the unequivocal presence of a saccular aneurysm \\>=3 mm treatable by endovascular methods. A catheter angiogram is required if there is doubt. Imaging studies will be reviewed centrally. Both treatments will be standardized. Patients will be followed similarly for a minimum of 10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one documented subarachnoid aneurysm, never ruptured\n* Patient aged 18 or older\n* Life expectancy more than 10 years\n\nExclusion Criteria:\n\n* Patients with recent (less than 3 months) intracranial haemorrhage\n* Lesion characteristics unsuitable for endovascular treatment\n* Patients with a single extradural aneurysm\n* Aneurysms \\< 3 mm or giant aneurysms (≥ 25 mm)\n* Patients with a poor outcome (Rankin scale ≥ 3) after the rupture, surgical or endovascular treatment of another aneurysm\n* Patients with incompletely treated aneurysms that have previously ruptured\n* Patients with associated arteriovenous malformations\n* Patients with new severe progressive symptoms in relationship with the aneurysm (sudden onset, severe persisting headaches suggestive of impending rupture, third-nerve palsy, mass-effect)\n* Patients with previous intracranial haemorrhage from unknown etiology\n* Patients with multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management\n* Patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium\n* Pregnant patients\n* Patients unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT00537134', 'acronym': 'TEAM', 'briefTitle': 'Trial on Endovascular Aneurysm Management', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Safety and Efficacy of Endovascular Treatment of Unruptured Intracranial Aneurysms in the Prevention of Aneurysmal Haemorrhages: A Randomized Comparison With Indefinite Deferral of Treatment in 2002 Patients Followed for 10 Years', 'orgStudyIdInfo': {'id': 'MCT-80799'}, 'secondaryIdInfos': [{'id': 'ISRCTN62758344', 'type': 'REGISTRY', 'domain': 'primary clinical trial registry recognised by WHO and ICMJE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conservative', 'description': 'Conservative management (watchful observation)'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endovascular', 'description': 'Endovascular treatment', 'interventionNames': ['Device: Embolization, coiling']}], 'interventions': [{'name': 'Embolization, coiling', 'type': 'DEVICE', 'otherNames': ['Standard and bioactive coils'], 'description': 'Endovascular embolization with platinum coils', 'armGroupLabels': ['Endovascular']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St Joseph's Hospital & Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Downstate Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10029-6504', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St Luke's-Roosevelt Hospital Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Reims', 'country': 'France', 'facility': 'TEAM France Coordination Unit - CHU Reims CRICAM', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'TEAM European Coordination Centre NVRU- Radcliffe Infirmary', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Jean Raymond, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre hospitalier de l'Université de Montréal - Hôpital Notre-Dame"}, {'name': 'Andrew J. Molyneux, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NRU, Radcliffe Infirmary Oxford University UK'}, {'name': 'Allan J Fox, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre and University of Toronto'}, {'name': 'Claiborne S. Johnston, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco, USA'}, {'name': 'Jean-Paul Collet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia, Vancouver, Canada'}, {'name': 'Isabelle Rouleau, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUM Hôpital Notre-Dame, Montreal, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}