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

Completed

• Conditions: Aortic Aneurysm; Aortic Aneurysm, Abdominal; Vascular Diseases; Aortic Diseases; Cardiovascular Diseases; Aneurysm
• Interventions: Device: Endurant Stent graft

• Registration Number: NCT01526811
• Lead Sponsor: Medtronic Cardiovascular

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-06
• Study Start: 2012-03
• Primary Completion: 2018-12-21
• Study Completion: 2018-12-21
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AAA patients	Endurant Stent graft	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

Primary Outcome Measures

Name	Time	Method
Surgical or endovascular secondary procedures	through 5 years
Aneurysm diameter's change	through 5 years
Conversion to open surgical repair	through 5 years
Stent graft endoleaks (type I, II and III)	through 5 years
Aneurysm-related mortality	through 5 years
All-cause mortality	through 5 years
Stent Graft migration	through 5 years

Trial Locations

Locations (20)

Médipôle de Savoie; 🇫🇷 Challes-les-Eaux, France

Hôpital Privé Sainte Marie; 🇫🇷 Chalon sur Saône, France

CHU de Besancon, Hôpital Jean Minjoz; 🇫🇷 Besançon, France

Groupe Hospitalier Henri-Mondor; 🇫🇷 Créteil, France

Centre Hospitalier d'Avignon; 🇫🇷 Avignon, France

Hôpital Privé Jean Mermoz; 🇫🇷 Lyon, France

Clinique de la Présentation; 🇫🇷 Fleury les Aubrais, France

CHU Limoges; 🇫🇷 Limoges, France

Hôpital Paul Desbief; 🇫🇷 Marseille, France

CHU Nice, Hôpital Saint-Roch; 🇫🇷 Nice, France

Polyclinique Quimper Sud; 🇫🇷 Quimper, France

Clinique Saint Joseph; 🇫🇷 Trélazé, France

Clinique Claude Bernard; 🇫🇷 Ermont, France

Clinique du Mousseau; 🇫🇷 Evry, France

Hôpital Ambroise Paré; 🇫🇷 Marseille, France

Hôpital Saint Joseph; 🇫🇷 Marseille, France

Clinique Belledonne; 🇫🇷 Saint-Martin-d'Hères, France

CHl Toulon - La Seyne sur Mer; 🇫🇷 Toulon, France

Clinique Sarrus Teinturiers; 🇫🇷 Toulouse, France

Clinique du Millenaire; 🇫🇷 Montpellier, France