The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System
Phase 1
Completed
- Conditions
- Aneurysms
- Registration Number
- NCT00288405
- Lead Sponsor
- Codman & Shurtleff
- Brief Summary
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.
Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
- Patients with intracranial, wide-neck, saccular aneurysms
Exclusion Criteria
- Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Successful stent placement with satisfactory coil mass position angiographically. immediately after post procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Azienda Ospedaliera
🇮🇹Milano, Italy