NCT00879580

Enterprise Stent Aneurysm Treatment (ESAT) Study - France

"Prospective Multicenter Observational Study for the Evaluation of the Efficacy of the Cordis Enterprise(TM) Self-expanding Intracranial Stent: Enterprise Stent Aneurysm Treatment (ESAT) Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 133 (actual)
• Sponsor: Codman & Shurtleff · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Aneurysm

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2009-04-10
• Last updated: 2013-10-11

Locations

14 sites across 1 country: France