Enterprise Stent Aneurysm Treatment (ESAT) Study - France

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT00879580
First received: March 31, 2009
Last updated: October 10, 2013
Last verified: October 2013
  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: February 2009
Study Completion Date: August 2013
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 10, 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 July 20, 2014