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

Sponsor

Medtronic Cardiovascular (Industry)

Overall Status

Completed

CT.gov ID

NCT01526811

Collaborator

(none)

180

Enrollment

Locations

81.7

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Vascular Diseases Cardiovascular Diseases Aortic Diseases	Device: Endurant Stent graft

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 Design

Study Type:

Observational

Actual Enrollment :

180 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Post-market Study on Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Dec 21, 2018

Actual Study Completion Date :

Dec 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
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	Device: Endurant Stent graft Endurant Stent graft implantation Other Names: EVAR

Arm

Intervention/Treatment

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

Device: Endurant Stent graft

Endurant Stent graft implantation

Other Names:

EVAR

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier d'Avignon	Avignon	France	84902
2	CHU de Besancon, Hôpital Jean Minjoz	Besançon	France	25030
3	Médipôle de Savoie	Challes-les-Eaux	France	73190
4	Hôpital Privé Sainte Marie	Chalon sur Saône	France	71100
5	Groupe Hospitalier Henri-Mondor	Créteil	France	94010
6	Clinique Claude Bernard	Ermont	France	95120
7	Clinique du Mousseau	Evry	France	91035
8	Clinique de la Présentation	Fleury les Aubrais	France	45404
9	CHU Limoges	Limoges	France	87042
10	Hôpital Privé Jean Mermoz	Lyon	France	69008
11	Hôpital Paul Desbief	Marseille	France	13002
12	Hôpital Ambroise Paré	Marseille	France	13006
13	Hôpital Saint Joseph	Marseille	France	13008
14	Clinique du Millenaire	Montpellier	France	34960
15	CHU Nice, Hôpital Saint-Roch	Nice	France	06006
16	Polyclinique Quimper Sud	Quimper	France	29000
17	Clinique Belledonne	Saint-Martin-d'Hères	France	38400
18	CHl Toulon - La Seyne sur Mer	Toulon	France	83056
19	Clinique Sarrus Teinturiers	Toulouse	France	31300
20	Clinique Saint Joseph	Trélazé	France	49800