Enterprise Stent Aneurysm Treatment (ESAT) Study - France
This study is ongoing, but not recruiting participants.
Sponsor:
Codman & Shurtleff
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT00879580
First received: March 31, 2009
Last updated: February 12, 2013
Last verified: February 2013
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Purpose
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.
| Condition |
|---|
|
Intracranial Aneurysm |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Codman & Shurtleff:
Primary Outcome Measures:
- Morbidity and Mortality [ Time Frame: Day 30 and 1 year post-procedure ] [ Designated as safety issue: Yes ]
| Enrollment: | 133 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879580
Locations
| France | |
| CHU Amiens | |
| Amiens, France, 80054 | |
| Jean Minjoz Hospital | |
| Besançon, France, 25030 | |
| Pellegrin Hospital | |
| Bordeaux, France, 33076 | |
| Albert Michallon Hospital | |
| Grenoble, France, 38043 | |
| Roger Salengro Hospital | |
| Lille, France, 59037 | |
| Timone Hospital | |
| Marseille, France, 13005 | |
| Lariboisiere Hospital | |
| Paris, France, 75010 | |
| La Pitie Salpetiere Hospital | |
| Paris, France, 75561 | |
| Beaujon Hospital | |
| Paris, France, 92118 | |
| Pitie Salpetriere Hospital | |
| Paris, France, 75561 | |
| Rothschild Foundation | |
| Paris, France, 75940 | |
| La Pitie Salpetriere Hospital | |
| Paris, France, 75651 | |
| White House Hospital | |
| Reims, France, 51092 | |
| Purpan Hospital | |
| Toulouse, France, 31059 | |
Sponsors and Collaborators
Codman & Shurtleff
Investigators
| Study Director: | Jonathan Megerian, MD, PhD | Codman & Shurtleff |
More Information
No publications provided
| Responsible Party: | Codman & Shurtleff |
| ClinicalTrials.gov Identifier: | NCT00879580 History of Changes |
| Other Study ID Numbers: | 07-FR-001 |
| Study First Received: | March 31, 2009 |
| Last Updated: | February 12, 2013 |
| Health Authority: | France: French Data Protection Authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) United States: Institutional Review Board |
Keywords provided by Codman & Shurtleff:
|
aneurysm stent intracranial aneurysm Ruptured Intracranial Aneurysm |
Additional relevant MeSH terms:
|
Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013