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

October 27, 2021 updated by: Medtronic Cardiovascular

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84902
        • Centre hospitalier d'Avignon
      • Besançon, France, 25030
        • CHU de Besançon, Hôpital Jean Minjoz
      • Challes-les-Eaux, France, 73190
        • Medipole de Savoie
      • Chalon sur Saône, France, 71100
        • Hôpital privé sainte Marie
      • Créteil, France, 94010
        • Groupe Hospitalier Henri-Mondor
      • Ermont, France, 95120
        • Clinique Claude Bernard
      • Evry, France, 91035
        • Clinique Du Mousseau
      • Fleury les Aubrais, France, 45404
        • Clinique de la Présentation
      • Limoges, France, 87042
        • CHU Limoges
      • Lyon, France, 69008
        • Hopital Prive Jean Mermoz
      • Marseille, France, 13002
        • Hopital Paul Desbief
      • Marseille, France, 13006
        • Hôpital Ambroise Paré
      • Marseille, France, 13008
        • Hopital Saint Joseph
      • Montpellier, France, 34960
        • Clinique du Millénaire
      • Nice, France, 06006
        • CHU Nice, Hôpital Saint-Roch
      • Quimper, France, 29000
        • Polyclinique Quimper Sud
      • Saint-Martin-d'Hères, France, 38400
        • Clinique Belledonne
      • Toulon, France, 83056
        • CHl Toulon - La Seyne sur Mer
      • Toulouse, France, 31300
        • Clinique Sarrus Teinturiers
      • Trélazé, France, 49800
        • Clinique Saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects diagnosed with a non-ruptured infra-renal abdominal aortic aneurysm (AAA) and requiring endovascular treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Investigators

  • Principal Investigator: Jean-Pierre Becquemin, MD, PhD, Groupe Hospitalier Henri-Mondor, Créteil, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

December 21, 2018

Study Completion (ACTUAL)

December 21, 2018

Study Registration Dates

First Submitted

January 27, 2012

First Submitted That Met QC Criteria

February 1, 2012

First Posted (ESTIMATE)

February 6, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P#8888

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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