NCT00288405

The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System

Cordis Neurovascular Feasibility Study of the Enterprise Self-Expanding Stent System to Facilitate Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Codman & Shurtleff · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Aneurysms

Interventions

Type	Name	Description
DEVICE	Cordis Self Expanding Stent

Timeline

• Start date: 2004-06-01
• Completion: 2005-12-01
• First posted: 2006-02-08
• Last updated: 2012-05-02

Locations

1 site across 1 country: Italy