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The objective of this study is to assess the benefits of endovascular technique in terms of efficacy and safety of Valiant Thoracic Stent Graft with the Captivia Delivery System in the treatment of thoracic aortic disease, in a cohort of patients representative of the population treated under real-life conditions of use in France for up to 5 years.
Data regarding the use under routine practice of thoracic aortic stent grafts in France are expected by the French National Authority for Health (HAS). Therefore, in its opinion report from December 22, 2009, 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 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 Valiant Thoracic Stent Graft with the Captivia Delivery System is registered on the LPPR for a period of 3 years since January 12, 2011. In order to comply with HAS expectations, Medtronic Bakken Research Center is setting up this long term non-interventional study on the Valiant Thoracic Stent Graft with the Captivia Delivery System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTA patients | 160 patients presenting with a disease of descending thoracic aorta(DTA)with an indication for endovascular treatment with Valiant Thoracic Stent Graft with the Captivia Delivery System and who meet the inclusion/exclusion criteria are intended to participate in this non-interventional. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTA patients (Valiant) | Device | Valiant Thoracic Stent Graft Implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Exclusion of aneurysm, penetrating aortic ulcer (PAU), false lumen or rupture site | Through 5 years | |
| Major Adverse Events | This includes respiratory, neurological, vascular, cardiac, renal, bleeding, visceral and infectious complications and any complication leading to death |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects diagnosed with a disease of descending thoracic aorta (DTA) and requiring endovascular treatment with Stent Graft.
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| Name | Affiliation | Role |
|---|---|---|
| Hervé Rousseau, MD, PhD | CHU Rangueil, 1 Avenue Jean Poulhes, TSA 50 032, 31059 TOULOUSE Cedex 9, FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie, Hôpital Sud | Amiens | 80054 | France | |||
| CHU de Bordeaux, Groupe Hospitalier Pellegrin |
Only multi center data will be available
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| Through 5 years |
| Conversion to open repair | Through 5 years |
| Endovascular or surgical secondary procedures | Through 5 years |
| Adverse device effects | Through 5 years |
| Thoracic disease-related mortality | Through 5 years |
| Bordeaux |
| 33000 |
| France |
| Hôpital Henri Mondor | Créteil | 94010 | France |
| CHU Grenoble, Hôpital A. Michallon | La Tronche | 38700 | France |
| Hôpital Privé de Parly 2 | Le Chesnay | 78150 | France |
| Centre Chirurgical Marie Lannelongue | Le Plessis-Robinson | 92350 | France |
| CHU de Limoges | Limoges | 87042 | France |
| Hôpital Privé Vert Coteau | Marseille | 13012 | France |
| Hôpital de la Timone | Marseille | 13385 | France |
| Hôpital Nord | Marseille | 13915 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Hôpital Pitié Salpêtrière | Paris | 75651 | France |
| Clinique Belledonne | Saint-Martin-d'Hères | 38400 | France |
| CHU de Saint-Etienne, Hôpital Nord | Saint-Priest-en-Jarez | 42270 | France |
| CHU Rangueil | Toulouse | 31059 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| Clinique du Tonkin | Villeurbanne | 69626 | France |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D000094629 | Dissection, Thoracic Aorta |
| D000094667 | Penetrating Atherosclerotic Ulcer |
| D001018 | Aortic Diseases |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000784 | Aortic Dissection |
| D000094665 | Dissection, Blood Vessel |
| D000094683 | Acute Aortic Syndrome |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |
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