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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526811
• Other study ID #: P#8888
• Status: Completed
• Start date: March 2012
• Est. completion date: December 21, 2018

Study information

• Verified date: October 2021
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Device:
• Endurant Stent graft
Endurant Stent graft implantation

Locations

Country	Name	City	State
France	Centre Hospitalier d'Avignon	Avignon
France	CHU de Besancon, Hôpital Jean Minjoz	Besançon
France	Médipôle de Savoie	Challes-les-Eaux
France	Hôpital Privé Sainte Marie	Chalon sur Saône
France	Groupe Hospitalier Henri-Mondor	Créteil
France	Clinique Claude Bernard	Ermont
France	Clinique du Mousseau	Evry
France	Clinique de la Présentation	Fleury les Aubrais
France	CHU Limoges	Limoges
France	Hôpital Privé Jean Mermoz	Lyon
France	Hôpital Ambroise Paré	Marseille
France	Hôpital Paul Desbief	Marseille
France	Hôpital Saint Joseph	Marseille
France	Clinique du Millenaire	Montpellier
France	CHU Nice, Hôpital Saint-Roch	Nice
France	Polyclinique Quimper Sud	Quimper
France	Clinique Belledonne	Saint-Martin-d'Hères
France	CHl Toulon - La Seyne sur Mer	Toulon
France	Clinique Sarrus Teinturiers	Toulouse
France	Clinique Saint Joseph	Trélazé

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

France, 

Outcome

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