Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)
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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 |
- 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 |
Subjects diagnosed with a non-ruptured infra-renal abdominal aortic aneurysm (AAA) and requiring endovascular treatment
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| France | |
| Clinique Générale d'Annecy | |
| Annecy, France, 74000 | |
| Hôpital Privé d'Antony | |
| Antony, France, 92166 | |
| 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 | |
| Polyclinique Notre Dame | |
| Draguignan, France, 83300 | |
| 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 | |
| Clinique Générale de Marignane | |
| Marignane, France, 13700 | |
| Hôpital Saint Joseph | |
| Marseille, France, 13008 | |
| Hôpital Paul Desbief | |
| Marseille, France, 13002 | |
| Hôpital Ambroise Paré | |
| Marseille, France, 13006 | |
| Clinique du Millenaire | |
| Montpellier, France, 34960 | |
| CHU Nice, Hôpital Saint-Roch | |
| Nice, France, 06006 | |
| Institut Mutualiste Montsouris | |
| Paris, France, 75014 | |
| Polyclinique Quimper Sud | |
| Quimper, France, 29000 | |
| Hôpital Privé de la Loire | |
| Saint Etienne, France, 42030 | |
| 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 | |
| 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: | April 15, 2013 |
| 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 Diseases |
Cardiovascular Diseases Vascular Diseases Aortic Aneurysm, Abdominal |
ClinicalTrials.gov processed this record on May 16, 2013