Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases (VALIANT CAPTIVIA France)
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|ClinicalTrials.gov Identifier: NCT01775046|
Recruitment Status : Active, not recruiting
First Posted : January 24, 2013
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment|
|Aortic Aneurysm, Thoracic Descending Thoracic Aortic Dissection Penetrating Ulcer Aorta Thoracic; Traumatic Rupture Aortic Diseases||Device: DTA patients (Valiant)|
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.
|Study Type :||Observational|
|Actual Enrollment :||160 participants|
|Official Title:||Post-market Study on Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases|
|Actual Study Start Date :||March 23, 2013|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||December 2021|
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.
Device: DTA patients (Valiant)
Valiant Thoracic Stent Graft Implantation
Other Name: TEVAR
- All-cause mortality [ Time Frame: 5 years ]
- Exclusion of aneurysm, penetrating aortic ulcer (PAU), false lumen or rupture site [ Time Frame: Through 5 years ]
- Major Adverse Events [ Time Frame: 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 [ Time Frame: Through 5 years ]
- Endovascular or surgical secondary procedures [ Time Frame: Through 5 years ]
- Adverse device effects [ Time Frame: Through 5 years ]
- Thoracic disease-related mortality [ Time Frame: Through 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775046
|Principal Investigator:||Hervé Rousseau, MD, PhD||CHU Rangueil, 1 Avenue Jean Poulhes, TSA 50 032, 31059 TOULOUSE Cedex 9, FRANCE|