Status:
COMPLETED
The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System
Lead Sponsor:
Codman & Shurtleff
Conditions:
Aneurysms
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 E...
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 eval...
Eligibility Criteria
Inclusion
- Patients with intracranial, wide-neck, saccular aneurysms
Exclusion
- Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00288405
Start Date
June 1 2004
End Date
December 1 2005
Last Update
May 2 2012
Active Locations (1)
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1
Azienda Ospedaliera
Milan, Italy, 20162