Overview

This trial is active, not recruiting.

Conditions aneurysm, aortic aneurysm, aortic aneurysm, abdominal, vascular diseases, cardiovascular diseases, aortic diseases
Treatment endurant stent graft
Sponsor Medtronic Endovascular
Start date March 2012
End date December 2018
Trial size 180 participants
Trial identifier NCT01526811, P#8888

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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 EVAR
Endurant Stent graft implantation

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Post-market Study on Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms
Principal investigator Jean-Pierre Becquemin, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Medtronic Endovascular.