Clinical trial NCT00879580: Enterprise Stent Aneurysm Treatment (ESAT) Study - France
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: aneurysm
stent
intracranial aneurysm
Ruptured Intracranial Aneurysm
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
First posted: 2009-04-10
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Morbidity and Mortality
timeFrame: Day 30 and 1 year post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Besançon
country: France
facility: Jean Minjoz Hospital
city: Bordeaux
country: France
facility: Pellegrin Hospital
city: Grenoble
country: France
facility: Albert Michallon Hospital
city: Lille
country: France
facility: Roger Salengro Hospital
city: Marseille
country: France
facility: Timone Hospital
city: Paris
country: France
facility: Lariboisiere Hospital
city: Paris
country: France
facility: La Pitie Salpetiere Hospital
city: Paris
country: France
facility: Pitie Salpetriere Hospital
city: Paris
country: France
facility: La Pitie Salpetriere Hospital
city: Paris
country: France
facility: Rothschild Foundation
city: Paris
country: France
facility: Beaujon Hospital
city: Reims
country: France
facility: White House Hospital
city: Toulouse
country: France
facility: Purpan Hospital
Study officials:
affiliation: Codman & Shurtleff
name: Jonathan Megerian, MD, PhD
role: STUDY_DIRECTOR
References: