We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enterprise Stent Aneurysm Treatment (ESAT) Study - France (ESAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00879580
Recruitment Status : Completed
First Posted : April 10, 2009
Last Update Posted : October 11, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Intracranial Aneurysm

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.


Study Design

Study Type : Observational
Actual Enrollment : 133 participants
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
Study Start Date : February 2009
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Morbidity and Mortality [ Time Frame: Day 30 and 1 year post-procedure ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Pitie Salpetriere Hospital
Paris, France, 75561
La Pitie Salpetriere Hospital
Paris, France, 75651
Rothschild Foundation
Paris, France, 75940
Beaujon Hospital
Paris, France, 92118
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

Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00879580     History of Changes
Other Study ID Numbers: 07-FR-001
First Posted: April 10, 2009    Key Record Dates
Last Update Posted: October 11, 2013
Last Verified: October 2013

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