Clinical Trial: Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases (VALIANT CAPTIVIA France)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Post-market Study on Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases

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 Summary:

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.


Sponsor: Medtronic Endovascular

Current Primary Outcome: All-cause mortality [ Time Frame: 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Medtronic Endovascular

Dates:
Date Received: January 21, 2013
Date Started: March 2013
Date Completion: December 2021
Last Updated: January 3, 2017
Last Verified: December 2016