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

March 31, 2009
October 10, 2013
February 2009
August 2013   (final data collection date for primary outcome measure)
Morbidity and Mortality [ Time Frame: Day 30 and 1 year post-procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00879580 on ClinicalTrials.gov Archive Site
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Not Provided
 
Enterprise Stent Aneurysm Treatment (ESAT) Study - France
"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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Intracranial Aneurysm
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  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00879580
07-FR-001
No
Codman & Shurtleff
Codman & Shurtleff
Not Provided
Study Director: Jonathan Megerian, MD, PhD Codman & Shurtleff
Codman & Shurtleff
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP