Enterprise Stent Aneurysm Treatment (ESAT) Study - France

Codman & Shurtleff133 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

133

Conditions

Intracranial Aneurysm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (14)

CHU Amiens

Amiens, France

Jean Minjoz Hospital

Besançon, France

Pellegrin Hospital

Bordeaux, France

Outcomes

Primary Outcomes

Morbidity and Mortality

Time frame: Day 30 and 1 year post-procedure

Data from ClinicalTrials.gov

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