Trials / Completed
CompletedNCT01775046
Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases (VALIANT CAPTIVIA France)
Post-market Study on Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 160 (actual)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
- Aortic Aneurysm, Thoracic
- Descending Thoracic Aortic Dissection
- Penetrating Ulcer
- Aorta Thoracic; Traumatic Rupture
- Aortic Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DTA patients (Valiant) | Valiant Thoracic Stent Graft Implantation |
Timeline
- Start date
- 2013-03-23
- Primary completion
- 2021-06-21
- Completion
- 2021-12-09
- First posted
- 2013-01-24
- Last updated
- 2022-02-09
Locations
17 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01775046. Inclusion in this directory is not an endorsement.