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

NCT ID: NCT01775046

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-23
• Study Completion Date: 2021-12-09

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.

Conditions

Aortic Aneurysm, Thoracic; Descending Thoracic Aortic Dissection; Penetrating Ulcer; Aorta Thoracic; Traumatic Rupture; Aortic Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

DTA patients (Valiant)

Intervention Type: DEVICE

Valiant Thoracic Stent Graft Implantation

Interventions

DTA patients (Valiant)

Valiant Thoracic Stent Graft Implantation

Intervention Type: DEVICE

Other Intervention Names

TEVAR

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hervé Rousseau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Rangueil, 1 Avenue Jean Poulhes, TSA 50 032, 31059 TOULOUSE Cedex 9, FRANCE

Locations

CHU Amiens Picardie, Hôpital Sud

Amiens, , France

CHU de Bordeaux, Groupe Hospitalier Pellegrin

Bordeaux, , France

Hôpital Henri Mondor

Créteil, , France

CHU Grenoble, Hôpital A. Michallon

La Tronche, , France

Hôpital Privé de Parly 2

Le Chesnay, , France

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, , France

CHU de Limoges

Limoges, , France

Hôpital Privé Vert Coteau

Marseille, , France

Hôpital de la Timone

Marseille, , France

Hôpital Nord

Marseille, , France

Hôpital Européen Georges Pompidou

Paris, , France

Hôpital Pitié Salpêtrière

Paris, , France

Clinique Belledonne

Saint-Martin-d'Hères, , France

CHU de Saint-Etienne, Hôpital Nord

Saint-Priest-en-Jarez, , France

CHU Rangueil

Toulouse, , France

Clinique Pasteur

Toulouse, , France

Clinique du Tonkin

Villeurbanne, , France

Countries

France

Other Identifiers

MDTVCFRANCE001

Identifier Type: -

Identifier Source: org_study_id