NCT01526811

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Endurant Stent graft	Endurant Stent graft implantation

Timeline

• Start date: 2012-03-01
• Primary completion: 2018-12-21
• Completion: 2018-12-21
• First posted: 2012-02-06
• Last updated: 2021-11-02

Locations

20 sites across 1 country: France