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.

Study Overview

• Status: Completed
• Conditions: Aortic Diseases; Aortic Aneurysm, Thoracic; Penetrating Ulcer; Descending Thoracic Aortic Dissection; Aorta Thoracic; Traumatic Rupture
• Intervention / Treatment: Device: DTA patients (Valiant)

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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens Picardie, Hôpital Sud
  • Bordeaux, France, 33000
    • CHU de Bordeaux, Groupe hospitalier Pellegrin
  • Créteil, France, 94010
    • Hôpital Henri Mondor
  • La Tronche, France, 38700
    • CHU Grenoble, Hôpital A. Michallon
  • Le Chesnay, France, 78150
    • Hôpital privé de Parly 2
  • Le Plessis-Robinson, France, 92350
    • Centre Chirurgical Marie Lannelongue
  • Limoges, France, 87042
    • CHU de Limoges
  • Marseille, France, 13385
    • Hôpital de la Timone
  • Marseille, France, 13915
    • Hôpital Nord
  • Marseille, France, 13012
    • Hôpital Privé Vert Coteau
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75651
    • Hopital Pitie Salpetriere
  • Saint Priest en Jarez, France, 42270
    • CHU de Saint-Etienne, Hopital Nord
  • Saint-Martin-d'Hères, France, 38400
    • Clinique Belledonne
  • Toulouse, France, 31059
    • CHU Rangueil
  • Toulouse, France, 31076
    • Clinique Pasteur
  • Villeurbanne, France, 69626
    • Clinique du Tonkin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: DTA patients (Valiant); Valiant Thoracic Stent Graft Implantation; Other Names: TEVAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exclusion of aneurysm, penetrating aortic ulcer (PAU), false lumen or rupture site		Through 5 years
Major Adverse Events	This includes respiratory, neurological, vascular, cardiac, renal, bleeding, visceral and infectious complications and any complication leading to death	Through 5 years
Conversion to open repair		Through 5 years
Endovascular or surgical secondary procedures		Through 5 years
Adverse device effects		Through 5 years
Thoracic disease-related mortality		Through 5 years

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Hervé Rousseau, MD, PhD, CHU Rangueil, 1 Avenue Jean Poulhes, TSA 50 032, 31059 TOULOUSE Cedex 9, FRANCE

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2013
• Primary Completion (ACTUAL): June 21, 2021
• Study Completion (ACTUAL): December 9, 2021

Study Registration Dates

• First Submitted: January 21, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (ESTIMATE): January 24, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Aortic; Thoracic; Stent Graft; Valiant; Captivia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Rupture; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aortic Diseases
• Other Study ID Numbers: MDTVCFRANCE001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only multi center data will be available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No