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

This study is currently recruiting participants.
Verified January 2014 by Medtronic Endovascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01775046
First received: January 21, 2013
Last updated: January 16, 2014
Last verified: January 2014

January 21, 2013
January 16, 2014
March 2013
July 2020   (final data collection date for primary outcome measure)
All-cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01775046 on ClinicalTrials.gov Archive Site
  • Exclusion of aneurysm, penetrating aortic ulcer (PAU), false lumen or rupture site [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
  • Major Adverse Events [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Endovascular or surgical secondary procedures [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
  • Adverse device effects [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
  • Thoracic disease-related mortality [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects diagnosed with a disease of descending thoracic aorta (DTA) and requiring endovascular treatment with Stent Graft.

  • Aortic Aneurysm, Thoracic
  • Descending Thoracic Aortic Dissection
  • Penetrating Ulcer
  • Aorta Thoracic; Traumatic Rupture
  • Aortic Diseases
Device: DTA patients (Valiant)
Valiant Thoracic Stent Graft Implantation
Other Name: TEVAR
DTA patients
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.
Intervention: Device: DTA patients (Valiant)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
July 2020
July 2020   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Manuel Girard +33474370312 manuel.girard@medtronic.com
Contact: Kristel Wittebols +31433566580 kristel.wittebols@medtronic.com
France
 
NCT01775046
MDTVCFRANCE001
No
Medtronic Endovascular
Medtronic Endovascular
Not Provided
Principal Investigator: Hervé Rousseau, MD, PhD CHU Rangueil, 1 Avenue Jean Poulhes, TSA 50 032, 31059 TOULOUSE Cedex 9, FRANCE
Medtronic Endovascular
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP