Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-30 @ 9:07 AM
Study NCT ID:
NCT04905303
Status:
WITHDRAWN
Last Update Posted:
2021-05-27
First Post:
2021-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Solitaire Aneurysm Remodeling Registry
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'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-24', 'studyFirstSubmitDate': '2021-05-24', 'studyFirstSubmitQcDate': '2021-05-24', 'lastUpdatePostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stable Stent placement with complete coverage across the aneurysm neck with parent artery patency', 'timeFrame': 'Six months post-implant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intracranial aneurysms', 'Wide neck aneurysms'], 'conditions': ['Intracranial Saccular Aneurysm, Either Rupture or Unruptured', 'Wide Neck Aneurysm']}, 'descriptionModule': {'briefSummary': 'The objective of the registry is to evaluate the effectiveness and performance of the Solitaire Neurovascular Remodeling Device when used with embolic coils in the treatment of intracranial aneurysms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with confirmed diagnosis of intracranial saccular aneurysm which can be treated with coil embolization and neurovascular stenting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of intracranial saccular aneurysms, either ruptured or unruptured\n* Aneurysm requires current treatment with coils and a stent or aneurysm hs been previously treated with coils, but no prior placement of a stent.\n* Aneurysm has a wide neck defined as having a neck equal to or greater than 4mm or a dome-to-neck ratio of \\<2.\n* Patient is 18 years or older.\n* Patient has a Hunt \\& Hess score of III or less.\n\nExclusion Criteria:\n\n* Patient has a fusiform or dissecting aneurysm type.\n* Patient is contraindicated for either heparin or anti-platelet therapy.\n* Patient has severe allergy to IV contrast medium.\n* Patient has a known hypersensitivity to nickel-titanium.'}, 'identificationModule': {'nctId': 'NCT04905303', 'briefTitle': 'Solitaire Aneurysm Remodeling Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Neurovascular Clinical Affairs'}, 'officialTitle': 'Prospective Multi-center, Single-arm Registry to Evaluate the Efficacy of the Solitaire AB Neurovascular Remodeling Device in the Treatment of Wide-neck Intracranial Aneurysms', 'orgStudyIdInfo': {'id': 'SOLARE'}}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Neurologique', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Neurovascular Clinical Affairs', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}