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Enterprise Stent Aneurysm Treatment (ESAT) Study - France — ESAT  

Intracranial Aneurysm Clinical Trial

Official title:
"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

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00879580
Study type Observational
Source Codman & Shurtleff
Contact
Status Completed
Phase N/A
Start date February 2009
Completion date August 2013
View Details
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