An observational study in Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection and Penetrating Ulcer, sponsored by Medtronic Cardiovascular. Completed at 17 sites in France. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Medtronic Cardiovascular (part of Medtronic) · Observational
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.
131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.
This study's enrollment of 160 is close to the median of 154 across 65 observational studies indexed under Aortic Aneurysm, Thoracic.
Browse Aortic Aneurysm, Thoracic studies →Medtronic Cardiovascular is the lead sponsor of 70 studies on the registry; 7 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects diagnosed with a disease of descending thoracic aorta (DTA) and requiring endovascular treatment with Stent Graft.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Also known as: 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
This includes respiratory, neurological, vascular, cardiac, renal, bleeding, visceral and infectious complications and any complication leading to death
Time frame: Through 5 years
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
Plan to share: No — Only multi center data will be available
No publications or documents are linked to this record.
Ran from Mar 2013 to primary completion in Jun 2021, 98 months.
Of 42 observational studies under Aortic Aneurysm, Thoracic, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 98. This study's 98 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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