Status:
COMPLETED
Enterprise Stent Aneurysm Treatment (ESAT) Study - France
Lead Sponsor:
Codman & Shurtleff
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18+ years
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 objectiv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00879580
Start Date
February 1 2009
End Date
August 1 2013
Last Update
October 11 2013
Active Locations (14)
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1
CHU Amiens
Amiens, France, 80054
2
Jean Minjoz Hospital
Besançon, France, 25030
3
Pellegrin Hospital
Bordeaux, France, 33076
4
Albert Michallon Hospital
Grenoble, France, 38043