Aorta Thoracic; Traumatic Rupture, Aortic Aneurysm, Thoracic, Aortic Diseases, Descending Thoracic Aortic Dissection, Penetrating Ulcer
Conditions
Keywords
Valiant, Captivia, Stent Graft, Thoracic, Aortic
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDTA patients (Valiant)
Valiant Thoracic Stent Graft Implantation
Sponsors
Medtronic Cardiovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any patient requiring placement of the Valiant Thoracic Stent Graft for the treatment of a disease of his/her descending thoracic aorta. * Patient or holder of parental authority not opposed to the collection and release of the personal information required by the study. * Patient or holder of parental authority has consented for study participation and the Medtronic approved Data Release Form has been signed and personally dated by patient or holder of parental authority and by the investigator.
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). * Prior implantation of a thoracic stent graft.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events | Through 5 years | This includes respiratory, neurological, vascular, cardiac, renal, bleeding, visceral and infectious complications and any complication leading to death |
| Conversion to open repair | Through 5 years | — |
| Exclusion of aneurysm, penetrating aortic ulcer (PAU), false lumen or rupture site | Through 5 years | — |
| Adverse device effects | Through 5 years | — |
| Thoracic disease-related mortality | Through 5 years | — |
| Endovascular or surgical secondary procedures | Through 5 years | — |
Countries
France
Outcome results
None listed