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Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)

NCT ID: NCT01526811

Last Updated: 2021-11-02

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

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2018-12-21

Brief Summary

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The purpose of this study is to assess the benefits of endovascular repair with Endurant Stent Graft System by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. at 5 years, in a cohort of patients representative of the population treated under real-life conditions of use in France.

Detailed Description

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Data regarding the use under routine practice of abdominal aortic stent grafts in France are expected by the French National Authority for Health (HAS). Therefore, in its opinion report from July 13, 2010, HAS makes the maintenance of reimbursement approval of each stent graft dependent on the presentation of results of a specific follow-up study carried out in a cohort of patients representative of the French population treated under real-life conditions of use. This prospective cohort study must involve at least 150 patients implanted after registration on the LPPR (List of Products and Services qualifying for Reimbursement). The results of the follow-up study must be forwarded to the National Committee for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) for examination once a year. The assessment of this follow-up could lead to the recommendation by CNEDiMTS to continue or stop the reimbursement of the concerned stent graft.

In France, The Endurant™ Stent Graft System is registered on the LPPR for a period of 3 years since September 13, 2011. In order to comply with HAS expectations, Medtronic Bakken Research Center is setting up this long term non-interventional study on the Endurant stent graft.

Conditions

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Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Vascular Diseases Cardiovascular Diseases Aortic Diseases

Keywords

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Endurant Stent Graft Abdominal Aortic Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AAA patients

Subjects presenting with a non-ruptured infra-renal abdominal aortic aneurysm (AAA) and requiring endovascular treatment with Endurant™ Stent Graft, and who meet the inclusion/exclusion criteria are intended to participate in this non-interventional study

Endurant Stent graft

Intervention Type DEVICE

Endurant Stent graft implantation

Interventions

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Endurant Stent graft

Endurant Stent graft implantation

Intervention Type DEVICE

Other Intervention Names

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EVAR

Eligibility Criteria

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Inclusion Criteria

* Patient with age ≥18 years, who is able to understand the information given by the investigator regarding the collection and release of his/her personal information and who is able to oppose to this collection and release.
* Any patient requiring placement of an abdominal aortic stent graft for the treatment of a non-ruptured infra-renal abdominal aortic aneurysm.
* Patient not opposed to the collection and release of his/her personal information
* Intention of physician to implant electively the Endurant™ Stent Graft System

Exclusion Criteria

* Patient in whom clinical follow-up will not be possible i.e. patient not able to come back for follow-up visits (ex. patient living abroad)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Pierre Becquemin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Henri-Mondor, Créteil, France

Locations

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Centre Hospitalier d'Avignon

Avignon, , France

Site Status

CHU de Besancon, Hôpital Jean Minjoz

Besançon, , France

Site Status

Médipôle de Savoie

Challes-les-Eaux, , France

Site Status

Hôpital Privé Sainte Marie

Chalon-sur-Saône, , France

Site Status

Groupe Hospitalier Henri-Mondor

Créteil, , France

Site Status

Clinique Claude Bernard

Ermont, , France

Site Status

Clinique du Mousseau

Évry, , France

Site Status

Clinique de la Présentation

Fleury-les-Aubrais, , France

Site Status

CHU Limoges

Limoges, , France

Site Status

Hôpital Privé Jean Mermoz

Lyon, , France

Site Status

Hôpital Paul Desbief

Marseille, , France

Site Status

Hôpital Ambroise Paré

Marseille, , France

Site Status

Hôpital Saint Joseph

Marseille, , France

Site Status

Clinique du Millenaire

Montpellier, , France

Site Status

CHU Nice, Hôpital Saint-Roch

Nice, , France

Site Status

Polyclinique Quimper Sud

Quimper, , France

Site Status

Clinique Belledonne

Saint-Martin-d'Hères, , France

Site Status

CHl Toulon - La Seyne sur Mer

Toulon, , France

Site Status

Clinique Sarrus Teinturiers

Toulouse, , France

Site Status

Clinique Saint Joseph

Trélazé, , France

Site Status

Countries

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France

Other Identifiers

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P#8888

Identifier Type: -

Identifier Source: org_study_id