Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-01-03 @ 10:40 AM
Study NCT ID:
NCT01811134
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2012-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial 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': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2012-11-20', 'studyFirstSubmitQcDate': '2013-03-12', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with complete occlusion of the treated aneurysm, defined as the absence of visible blood flow on angiography performed 12 months after endovascular procedure.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Occurrence of a death during or after endovascular procedure', 'timeFrame': 'hospitalization for the endovascular procedure, up to 7 days'}, {'measure': 'Occurrence of a death whatever the cause', 'timeFrame': '24 months'}, {'measure': 'Occurrence of a death due to aneurysm rupture', 'timeFrame': '24 months'}, {'measure': 'Occurrence of an intracranial hemorrhagic from rupture of the aneurysm', 'timeFrame': '24 months'}, {'measure': 'Occurrence of an ischemic stroke due to thrombosis', 'timeFrame': '24 months'}, {'measure': 'Occurrence of a non-cerebral bleeding', 'timeFrame': '24 months'}, {'measure': 'Rate of patients with neurological deficits by mass effect', 'timeFrame': 'hospitalization for the endovascular procedure, an expected average of 1 hour; 3 months, 6 months and 12 months post-intervention'}, {'measure': 'Retreatment of the aneurysm', 'timeFrame': '24 months'}, {'measure': 'Rate of technical complications', 'timeFrame': 'Endovascular procedure an expected average of 1 hour'}, {'measure': 'Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others', 'timeFrame': 'Endovascular procedure an expected average of 1 hour'}, {'measure': 'Rate of correct placement of flow diverter stents, according to the investigator', 'timeFrame': 'Endovascular procedure an expected average of 1 hour'}, {'measure': 'mean duration of irradiation related to angiography', 'timeFrame': 'Endovascular procedure an expected average of 1 hour'}, {'measure': 'Rate of patients for each class of occlusion', 'timeFrame': 'Endovascular procedure , an expected average of 1 hour and 12 months', 'description': 'The classes of occlusion are defined as : complete occlusion, residual neck, residual aneurysm, for the group treated with coiling procedure; grades 0 to 4 according to the scale of Kamran, for the group treated with flow diversion'}, {'measure': 'Modified Rankin score', 'timeFrame': 'Inclusion, 3 months and 12 months'}, {'measure': 'National Institute of Health Stroke Score (NIHSS)', 'timeFrame': 'Inclusion, 3 months and 12 months'}, {'measure': 'Evolution of the Barthel index', 'timeFrame': ': Inclusion and 12 months'}, {'measure': 'Incremental cost-effectiveness ratio', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['endovascular procedure; flow diverter stent'], 'conditions': ['Intracranial Aneurysm']}, 'referencesModule': {'references': [{'pmid': '25280445', 'type': 'RESULT', 'citation': 'Turjman F, Levrier O, Combaz X, Bonafe A, Biondi A, Desal H, Bracard S, Mounayer C, Riva R, Chapuis F, Huot L, Armoiry X, Gory B. EVIDENCE trial: design of a phase 2, randomized, controlled, multicenter study comparing flow diversion and traditional endovascular strategy in unruptured saccular wide-necked intracranial aneurysms. Neuroradiology. 2015 Jan;57(1):49-54. doi: 10.1007/s00234-014-1439-7. Epub 2014 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance. A new endovascular technique has recently been developed, using flow diverter stents without associated coils. Clinical results already published are encouraging but have to be confirmed. Furthermore, these medical devices are expensive in comparison to the coiling strategy. The purpose of this study is to compare the clinical efficacy, safety, and cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted saccular intracranial aneurysms.', 'detailedDescription': 'Main Outcome Measure: Percentage of patients with an aneurysm with complete occlusion, defined as the absence of visible blood flow to the consideration of angiography performed 12 months post-endovascular intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient\'s age ≥ 18 years old\n* Unruptured saccular intracranial aneurysm diagnosed by angiography or CT angiography or MR angiography, located in the intra-dural area, with a neck diameter between 4 and 10 mm, with a sac diameter between 7 mm and 20 mm, with a ratio "dome/nek" greater than 1, and with a diameter of the parent artery between 2 and 5 mm.\n* No prior treatment of the aneurysm\n* Agreement for participating in the study and informed consent signed by the patient\n* Patient affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Patient\'s age \\< 18 years old\n* Adult patient protected by law\n* Contraindications to the endovascular procedure\n* Contraindications to antiplatelet or anticoagulant treatment\n* Prior treatment of the aneurysm\n* Presence of an arteriovenous malformation\n* Extradural location of the aneurysm\n* Fusiform aneurysm\n* Active bacterial infection (clinical signs)\n* Intracranial hemorrhage from aneurysm in the previous month\n* Pregnant or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT01811134', 'acronym': 'EVIDENCE', 'briefTitle': 'Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Multicenter Randomized Study for Medico-economic Evaluation of Embolization With Flow Diverter Stent in the Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms', 'orgStudyIdInfo': {'id': '2011.689'}, 'secondaryIdInfos': [{'id': '2011-A01079-32', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PIPELINE flow diverter stent', 'description': 'flow diverter stent', 'interventionNames': ['Device: PIPELINE flow diverter stent', 'Device: Coils, with or without expendable stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Coils, with or without expendable stent', 'description': 'Coils', 'interventionNames': ['Device: PIPELINE flow diverter stent', 'Device: Coils, with or without expendable stent']}], 'interventions': [{'name': 'PIPELINE flow diverter stent', 'type': 'DEVICE', 'description': 'endovascular procedure using the medical device PIPELINE', 'armGroupLabels': ['Coils, with or without expendable stent', 'PIPELINE flow diverter stent']}, {'name': 'Coils, with or without expendable stent', 'type': 'DEVICE', 'description': 'endovascular embolization procedure using microspires, with the possibility of using a balloon temporary and / or implantation of a stent complementary intracranial before implementation of microspires', 'armGroupLabels': ['Coils, with or without expendable stent', 'PIPELINE flow diverter stent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'state': 'BRON', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Francis TURJMAN, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}