Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endurant Stent graft | Device | Endurant Stent graft implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | through 5 years | |
| Aneurysm diameter's change | through 5 years | |
| Stent graft endoleaks (type I, II and III) | through 5 years | |
| Stent Graft migration | through 5 years | |
| Conversion to open surgical repair | through 5 years | |
| Surgical or endovascular secondary procedures | through 5 years | |
| Aneurysm-related mortality | through 5 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects diagnosed with a non-ruptured infra-renal abdominal aortic aneurysm (AAA) and requiring endovascular treatment
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre Becquemin, MD, PhD | Groupe Hospitalier Henri-Mondor, Créteil, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Avignon | Avignon | 84902 | France | |||
| CHU de Besancon, Hôpital Jean Minjoz |
Not provided
Not provided
Not provided
Not provided
| Besançon |
| 25030 |
| France |
| Médipôle de Savoie | Challes-les-Eaux | 73190 | France |
| Hôpital Privé Sainte Marie | Chalon-sur-Saône | 71100 | France |
| Groupe Hospitalier Henri-Mondor | Créteil | 94010 | France |
| Clinique Claude Bernard | Ermont | 95120 | France |
| Clinique du Mousseau | Évry | 91035 | France |
| Clinique de la Présentation | Fleury-les-Aubrais | 45404 | France |
| CHU Limoges | Limoges | 87042 | France |
| Hôpital Privé Jean Mermoz | Lyon | 69008 | France |
| Hôpital Paul Desbief | Marseille | 13002 | France |
| Hôpital Ambroise Paré | Marseille | 13006 | France |
| Hôpital Saint Joseph | Marseille | 13008 | France |
| Clinique du Millenaire | Montpellier | 34960 | France |
| CHU Nice, Hôpital Saint-Roch | Nice | 06006 | France |
| Polyclinique Quimper Sud | Quimper | 29000 | France |
| Clinique Belledonne | Saint-Martin-d'Hères | 38400 | France |
| CHl Toulon - La Seyne sur Mer | Toulon | 83056 | France |
| Clinique Sarrus Teinturiers | Toulouse | 31300 | France |
| Clinique Saint Joseph | Trélazé | 49800 | France |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D001014 | Aortic Aneurysm |
| D017544 | Aortic Aneurysm, Abdominal |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
Not provided
Not provided
Not provided