Clinical trial NCT01526811: Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)
Official title: Post-market Study on Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Keywords: Endurant
Stent Graft
Abdominal Aortic Aneurysm
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-02-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with a non-ruptured infra-renal abdominal aortic aneurysm (AAA) and requiring endovascular treatment

Brief 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.

Eligibility 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)

Primary outcomes:
measure: All-cause mortality
timeFrame: through 5 years
measure: Aneurysm diameter's change
timeFrame: through 5 years
measure: Stent graft endoleaks (type I, II and III)
timeFrame: through 5 years
measure: Stent Graft migration
timeFrame: through 5 years
measure: Conversion to open surgical repair
timeFrame: through 5 years
measure: Surgical or endovascular secondary procedures
timeFrame: through 5 years
measure: Aneurysm-related mortality
timeFrame: through 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon
city: Besançon
country: France
facility: CHU de Besancon, Hôpital Jean Minjoz
city: Challes-les-Eaux
country: France
facility: Médipôle de Savoie
city: Chalon sur Saône
country: France
facility: Hôpital Privé Sainte Marie
city: Créteil
country: France
facility: Groupe Hospitalier Henri-Mondor
city: Ermont
country: France
facility: Clinique Claude Bernard
city: Evry
country: France
facility: Clinique du Mousseau
city: Fleury les Aubrais
country: France
facility: Clinique de la Présentation
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
city: Marseille
country: France
facility: Hôpital Paul Desbief
city: Marseille
country: France
facility: Hôpital Ambroise Paré
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Montpellier
country: France
facility: Clinique du Millenaire
city: Nice
country: France
facility: CHU Nice, Hôpital Saint-Roch
city: Quimper
country: France
facility: Polyclinique Quimper Sud
city: Saint-Martin-d'Hères
country: France
facility: Clinique Belledonne
city: Toulon
country: France
facility: CHl Toulon - La Seyne sur Mer
city: Toulouse
country: France
facility: Clinique Sarrus Teinturiers
city: Trélazé
country: France
facility: Clinique Saint Joseph
Study officials:
affiliation: Groupe Hospitalier Henri-Mondor, Créteil, France
name: Jean-Pierre Becquemin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: