Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-04 @ 4:12 PM
Study NCT ID:
NCT02862756
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2016-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-12', 'studyFirstSubmitDate': '2016-08-08', 'studyFirstSubmitQcDate': '2016-08-08', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thromboembolic complication', 'timeFrame': '72 hours after endovascular treatment', 'description': 'Thromboembolic complication diagnosed using diffusion-weighted MRI'}]}, 'conditionsModule': {'conditions': ['Unruptured Intracranial Aneurysms']}, 'referencesModule': {'references': [{'pmid': '39095086', 'type': 'DERIVED', 'citation': 'Pierot L, Rouchaud A, Chabert E, Desal H, Ricolfi F, Barbe C, Soize S, Zerroug A, Eugene F, Clarencon F, Ferre JC. Endovascular treatment of unruptured intracranial aneurysms: Rate of thromboembolic events depicted by diffusion-weighted imaging in relation to different techniques. J Neurointerv Surg. 2025 Aug 13;17(9):949-955. doi: 10.1136/jnis-2024-022051.'}]}, 'descriptionModule': {'briefSummary': 'Endovascular treatment of ruptured and unruptured intracranial aneurysms presents complications, mainly the thrombo-embolic complication. No specific studies have been conducted to study factors associated with the occurrence of thromboembolic complications (symptomatic or not) post endovascular treatment of intracranial aneurysms.', 'detailedDescription': 'In this multicenter, prospective study, patients with treatment of unruptured intracranial aneurysms will be recruited. The thromboembolic complications will be research using diffusion-weighted MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient having a programmed endovascular treatment for unruptured intracranial aneurysm\n* patient older than 18 years\n* patient consenting to participate to the study\n* patient enrolled in the national healthcare insurance program\n\nExclusion Criteria:\n\n* patients with contraindications for MRI\n* patients whose clinical condition does not allow sufficient cooperation to the realization of MRI\n* patients with arteriovenous malformation intracranial'}, 'identificationModule': {'nctId': 'NCT02862756', 'acronym': 'ACET', 'briefTitle': 'Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms', 'orgStudyIdInfo': {'id': 'PR16021*'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient with endovascular treatment', 'interventionNames': ['Other: diffusion-weighted MRI and clinical examination']}], 'interventions': [{'name': 'diffusion-weighted MRI and clinical examination', 'type': 'OTHER', 'armGroupLabels': ['patient with endovascular treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Chu de Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}