Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT00288405
Status:
COMPLETED
Last Update Posted:
2012-05-02
First Post:
2005-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-30', 'studyFirstSubmitDate': '2005-10-05', 'studyFirstSubmitQcDate': '2006-02-06', 'lastUpdatePostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful stent placement with satisfactory coil mass position angiographically.', 'timeFrame': 'immediately after post procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intracranial', 'Wide-neck', 'Saccular', 'Aneurysms'], 'conditions': ['Aneurysms']}, 'referencesModule': {'references': [{'pmid': '16091525', 'type': 'BACKGROUND', 'citation': 'Higashida RT, Halbach VV, Dowd CF, Juravsky L, Meagher S. Initial clinical experience with a new self-expanding nitinol stent for the treatment of intracranial cerebral aneurysms: the Cordis Enterprise stent. AJNR Am J Neuroradiol. 2005 Aug;26(7):1751-6.'}, {'pmid': '17476494', 'type': 'RESULT', 'citation': 'Weber W, Bendszus M, Kis B, Boulanger T, Solymosi L, Kuhne D. A new self-expanding nitinol stent (Enterprise) for the treatment of wide-necked intracranial aneurysms: initial clinical and angiographic results in 31 aneurysms. Neuroradiology. 2007 Jul;49(7):555-61. doi: 10.1007/s00234-007-0232-2. Epub 2007 May 3.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent System to facilitate endovascular coil embolization of wide neck saccular intracranial aneurysms.\n\nCordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel', 'detailedDescription': 'This is a multi-center, prospective, non-randomized feasibility study including 30 subjects. Subjects will receive a safety follow-up evaluation at 30 days (+ two weeks) and an efficacy follow-up evaluation at 6 months (+ four weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with intracranial, wide-neck, saccular aneurysms\n\nExclusion Criteria:\n\n* Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage'}, 'identificationModule': {'nctId': 'NCT00288405', 'briefTitle': 'The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Codman & Shurtleff'}, 'officialTitle': 'Cordis Neurovascular Feasibility Study of the Enterprise Self-Expanding Stent System to Facilitate Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms', 'orgStudyIdInfo': {'id': 'EN-03-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cordis Self Expanding Stent', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'Azienda Ospedaliera', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Edoardo Boccardi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliera'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Codman & Shurtleff', 'class': 'INDUSTRY'}}}}