Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-02-27 @ 11:05 AM
Study NCT ID:
NCT03844334
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2019-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLinical EValuation of WEB 0.017 Device in 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2019-02-15', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aneurysm occlusion', 'timeFrame': '12 months', 'description': 'Angiographic (conventional Angio) occlusion based on Raymond-Roy occlusion scale The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms.\n\n* class I: complete obliteration\n* class II: residual neck\n* class III: residual aneurysm'}, {'measure': 'Incidence of major stroke or neurological deaths', 'timeFrame': '12months', 'description': 'The proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Aneurysm']}, 'referencesModule': {'references': [{'pmid': '37914392', 'type': 'DERIVED', 'citation': 'Spelle L, Costalat V, Caroff J, Wodarg F, Fischer S, Herbreteau D, Mohlenbruch MA, Januel AC, Papagiannaki C, Klisch J, Numminen J, Rautio R, Berlis A, Mihalea C, Chalumeau V, Downer J, Cortese J, Ikka L, Gallas S, Bester M, Liebig T, Velasco S, Grimaldi L, Byrne J, Szikora I, Pierot L, Cognard C. CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms. J Neurointerv Surg. 2024 Nov 22;16(12):1299-1306. doi: 10.1136/jnis-2023-020866.'}], 'seeAlsoLinks': [{'url': 'https://jnis.bmj.com/content/early/2023/11/01/jnis-2023-020866.long', 'label': 'CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms'}]}, 'descriptionModule': {'briefSummary': 'The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.', 'detailedDescription': "All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled.\n\nSubjects will be followed per Institution's standard of care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The decision to use a WEB device to treat the patient has been made before and independently of the decision to include the patient in this study', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject must be ≥ 18 years of age and ≤80 years of age\n2. Subject must have an intracranial aneurysm (IA),\n3. Subject must sign and date Ethics Committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection\n4. For ruptured aneurysm, Subject with Hunt \\& Hess Score ≤ III\n\nExclusion Criteria:\n\n1. Subject has an IA with characteristics unsuitable for endovascular treatment\n2. Subject's index IA was previously treated\n3. Subject has stroke-in-evolution within the prior 30 days\n4. An additional aneurysm must be treated during the procedure"}, 'identificationModule': {'nctId': 'NCT03844334', 'acronym': 'CLEVER', 'briefTitle': 'CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Microvention-Terumo, Inc.'}, 'officialTitle': 'CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms', 'orgStudyIdInfo': {'id': 'CIP EMEA 18-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'WEB Aneurysm Embolization System', 'type': 'DEVICE', 'description': 'Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured or unruptured intracranial aneurysms.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Hôpital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '44892', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Universitätsklinikum Knappschaftskrankenhaus', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '1145', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'National Institute of Clinical Neurosciences', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Microvention-Terumo, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}