Enterprise Stent Aneurysm Treatment (ESAT) Study - France

Intracranial Aneurysm Clinical Trial

— ESAT  

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 Details — Status: Completed

Administrative data

• NCT number: NCT00879580
• Other study ID #: 07-FR-001
• Status: Completed
• Phase: N/A
• First received: March 31, 2009
• Last updated: October 10, 2013
• Start date: February 2009
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection AuthorityFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	Jean Minjoz Hospital	Besançon
France	Pellegrin Hospital	Bordeaux
France	Albert Michallon Hospital	Grenoble
France	Roger Salengro Hospital	Lille
France	Timone Hospital	Marseille
France	Beaujon Hospital	Paris
France	La Pitie Salpetiere Hospital	Paris
France	La Pitie Salpetriere Hospital	Paris
France	Lariboisiere Hospital	Paris
France	Pitie Salpetriere Hospital	Paris
France	Rothschild Foundation	Paris
France	White House Hospital	Reims
France	Purpan Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Codman & Shurtleff

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity and Mortality		Day 30 and 1 year post-procedure	Yes