Enterprise Stent Aneurysm Treatment (ESAT) Study - France

Completed

• Conditions: Intracranial Aneurysm

• Registration Number: NCT00879580
• Lead Sponsor: Codman & Shurtleff

Brief Summary

The purpose of this study is to evaluate the morbidity, mortality, and efficacy of use of the Enterprise(TM) stent for the treatment of (ruptured or non-ruptured) intracranial aneurysms.

Detailed Description

Per the opinion of the Commission for the Evaluation of Products and Services (CEPP) in France, renewal is contingent upon setup of a prospective morbidity, mortality, and efficacy study. The objective is to follow the stented Subjects for at least 1 year and evaluate the device and practices.

This will be a multicenter study involving up to 15 interventional neuroradiologists in France. Subjects presenting with ruptured or non-ruptured aneurysms for whom simple or balloon assisted endovascular treatment is considered impossible or insufficient by the interventional neuroradiologist.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-04-09
• Study First Posted: 2009-04-10
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-10
• Last Update Posted: 2013-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• Patient implanted with one or more CODMAN ENTERPRISE™ stents and who present one or more ruptured or non-ruptured intracranial aneurysms assessed by angiography
• Agreement to take part in the study by the patient, or a representative of the patient in case of patient inability, after being informed by the investigator and have received information letter.

Exclusion Criteria

• Minors <18 years of age
• Patient implanted for the same aneurysm with a CODMAN ENTERPRISE™ stent in association with one or more stents from a different brand.
• Patient who does not accept to take part in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morbidity and Mortality	Day 30 and 1 year post-procedure

Trial Locations

Locations (14)

CHU Amiens; 🇫🇷 Amiens, France

Roger Salengro Hospital; 🇫🇷 Lille, France

La Pitie Salpetiere Hospital; 🇫🇷 Paris, France

Lariboisiere Hospital; 🇫🇷 Paris, France

La Pitie Salpetriere Hospital; 🇫🇷 Paris, France

Purpan Hospital; 🇫🇷 Toulouse, France

Albert Michallon Hospital; 🇫🇷 Grenoble, France

Jean Minjoz Hospital; 🇫🇷 Besançon, France

Pitie Salpetriere Hospital; 🇫🇷 Paris, France

Rothschild Foundation; 🇫🇷 Paris, France

Beaujon Hospital; 🇫🇷 Paris, France

Pellegrin Hospital; 🇫🇷 Bordeaux, France

Timone Hospital; 🇫🇷 Marseille, France

White House Hospital; 🇫🇷 Reims, France