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

Codman & Shurtleff1 site in 1 country31 target enrollmentJune 2004

ConditionsAneurysms

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Aneurysms
Sponsor: Codman & Shurtleff
Enrollment: 31
Locations: 1
Primary Endpoint: Successful stent placement with satisfactory coil mass position angiographically.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

June 2004

End Date

December 2005

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group