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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01526811
First received: January 27, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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 Intervention
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Device: Endurant Stent graft

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: through 5 years ] [ Designated as safety issue: No ]
  • Aneurysm diameter's change [ Time Frame: through 5 years ] [ Designated as safety issue: No ]
  • Stent graft endoleaks (type I, II and III) [ Time Frame: through 5 years ] [ Designated as safety issue: No ]
  • Stent Graft migration [ Time Frame: through 5 years ] [ Designated as safety issue: No ]
  • Conversion to open surgical repair [ Time Frame: through 5 years ] [ Designated as safety issue: No ]
  • Surgical or endovascular secondary procedures [ Time Frame: through 5 years ] [ Designated as safety issue: No ]
  • Aneurysm-related mortality [ Time Frame: through 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: March 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: EVAR

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526811

Locations
France
Centre Hospitalier d'Avignon
Avignon, France, 84902
CHU de Besancon, Hôpital Jean Minjoz
Besançon, France, 25030
Médipôle de Savoie
Challes-les-Eaux, France, 73190
Hôpital Privé Sainte Marie
Chalon sur Saône, France, 71100
Groupe Hospitalier Henri-Mondor
Créteil, France, 94010
Clinique Claude Bernard
Ermont, France, 95120
Clinique du Mousseau
Evry, France, 91035
Clinique de la Présentation
Fleury les Aubrais, France, 45404
CHU Limoges
Limoges, France, 87042
Hôpital Privé Jean Mermoz
Lyon, France, 69008
Hôpital Paul Desbief
Marseille, France, 13002
Hôpital Saint Joseph
Marseille, France, 13008
Hôpital Ambroise Paré
Marseille, France, 13006
Clinique du Millenaire
Montpellier, France, 34960
Polyclinique Quimper Sud
Quimper, France, 29000
Clinique Belledonne
Saint-Martin-d'Hères, France, 38400
CHl Toulon - La Seyne sur Mer
Toulon, France, 83056
Clinique Sarrus Teinturiers
Toulouse, France, 31300
Clinique Saint Joseph
Trélazé, France, 49800
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Jean-Pierre Becquemin, MD, PhD Groupe Hospitalier Henri-Mondor, Créteil, France
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01526811     History of Changes
Other Study ID Numbers: P#8888
Study First Received: January 27, 2012
Last Updated: July 10, 2014
Health Authority: France: Haute Autorité de Santé Transparency Commission

Keywords provided by Medtronic Endovascular:
Endurant
Stent Graft
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014