Enterprise Stent Aneurysm Treatment (ESAT) Study - France
ESAT
"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
1 other identifier
observational
133
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2009
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 31, 2009
CompletedFirst Posted
Study publicly available on registry
April 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedOctober 11, 2013
October 1, 2013
4.5 years
March 31, 2009
October 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morbidity and Mortality
Day 30 and 1 year post-procedure
Study Arms (2)
Non-ruptured aneurysms
Patients with intracranial aneurysm(s) requiring an endovascular treatment with a Codman ENTERPRISE stent who have one or more non-ruptured or late ruptured (\>30days), intracranial aneurysm.
Acute ruptured Aneurysms
Patients with intracranial aneurysm(s) requiring an endovascular treatment with a Codman ENTERPRISE stent who have a on or more acute ruptured (\<30Days) aneurysms
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
CHU Amiens
Amiens, 80054, France
Jean Minjoz Hospital
Besançon, 25030, France
Pellegrin Hospital
Bordeaux, 33076, France
Albert Michallon Hospital
Grenoble, 38043, France
Roger Salengro Hospital
Lille, 59037, France
Timone Hospital
Marseille, 13005, France
Lariboisiere Hospital
Paris, 75010, France
La Pitie Salpetiere Hospital
Paris, 75561, France
Pitie Salpetriere Hospital
Paris, 75561, France
La Pitie Salpetriere Hospital
Paris, 75651, France
Rothschild Foundation
Paris, 75940, France
Beaujon Hospital
Paris, 92118, France
White House Hospital
Reims, 51092, France
Purpan Hospital
Toulouse, 31059, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jonathan Megerian, MD, PhD
Codman & Shurtleff
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2009
First Posted
April 10, 2009
Study Start
February 1, 2009
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
October 11, 2013
Record last verified: 2013-10