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

Completed

• Conditions: Aortic Aneurysm, Thoracic; Aortic Diseases; Descending Thoracic Aortic Dissection; Penetrating Ulcer; Aorta Thoracic; Traumatic Rupture
• Interventions: Device: DTA patients (Valiant)

• Registration Number: NCT01775046
• Lead Sponsor: Medtronic Cardiovascular

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 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 Timeline

• Study First Submitted: 2013-01-21
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-24
• Study Start: 2013-03-23
• Primary Completion: 2021-06-21
• Study Completion: 2021-12-09
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DTA patients	DTA patients (Valiant)	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.

Primary Outcome Measures

Name	Time	Method
All-cause mortality	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (17)

CHU Amiens Picardie, Hôpital Sud; 🇫🇷 Amiens, France

Clinique du Tonkin; 🇫🇷 Villeurbanne, France

CHU Rangueil; 🇫🇷 Toulouse, France

CHU de Bordeaux, Groupe Hospitalier Pellegrin; 🇫🇷 Bordeaux, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

CHU Grenoble, Hôpital A. Michallon; 🇫🇷 La Tronche, France

Centre Chirurgical Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, France

Hôpital Privé de Parly 2; 🇫🇷 Le Chesnay, France

Hôpital Privé Vert Coteau; 🇫🇷 Marseille, France

Hôpital Nord; 🇫🇷 Marseille, France

CHU de Limoges; 🇫🇷 Limoges, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Hôpital de la Timone; 🇫🇷 Marseille, France

Hôpital Pitié Salpêtrière; 🇫🇷 Paris, France

Clinique Belledonne; 🇫🇷 Saint-Martin-d'Hères, France

CHU de Saint-Etienne, Hôpital Nord; 🇫🇷 Saint Priest en Jarez, France

Clinique Pasteur; 🇫🇷 Toulouse, France