Enterprise Stent Aneurysm Treatment (ESAT) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intracranial Aneurysm

Keywords

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aneurysm stent intracranial aneurysm Ruptured Intracranial Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Megerian, MD, PhD

Role: STUDY_DIRECTOR

Codman & Shurtleff

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France

Other Identifiers

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07-FR-001

Identifier Type: -

Identifier Source: org_study_id

Enterprise Stent Aneurysm Treatment (ESAT) Study - France

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Non-ruptured aneurysms

Acute ruptured Aneurysms

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Codman & Shurtleff

Responsible Party

Principal Investigators

Jonathan Megerian, MD, PhD

Locations

CHU Amiens

Jean Minjoz Hospital

Pellegrin Hospital

Albert Michallon Hospital

Roger Salengro Hospital

Timone Hospital

Lariboisiere Hospital

La Pitie Salpetiere Hospital

Pitie Salpetriere Hospital

La Pitie Salpetriere Hospital

Rothschild Foundation

Beaujon Hospital

White House Hospital

Purpan Hospital

Countries

Other Identifiers

07-FR-001