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

NCT01775046 | Completed

• 1 other identifier: MDTVCFRANCE001
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 17

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.

Conditions

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

Keywords

Valiant; Captivia; Stent Graft; Thoracic; Aortic

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  5 years

Secondary Outcomes (6)

• Exclusion of aneurysm, penetrating aortic ulcer (PAU), false lumen or rupture site

  Through 5 years

• Major Adverse Events

  Through 5 years

• Conversion to open repair

  Through 5 years

• Endovascular or surgical secondary procedures

  Through 5 years

• Adverse device effects

  Through 5 years

Study Arms (1)

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)

Interventions

DTA patients (Valiant) DEVICE

Valiant Thoracic Stent Graft Implantation

Also known as: TEVAR

DTA patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (17)

CHU Amiens Picardie, Hôpital Sud

Amiens, 80054, France

Location

CHU de Bordeaux, Groupe Hospitalier Pellegrin

Bordeaux, 33000, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU Grenoble, Hôpital A. Michallon

La Tronche, 38700, France

Location

Hôpital Privé de Parly 2

Le Chesnay, 78150, France

Location

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

CHU de Limoges

Limoges, 87042, France

Location

Hôpital Privé Vert Coteau

Marseille, 13012, France

Location

Hôpital de la Timone

Marseille, 13385, France

Location

Hôpital Nord

Marseille, 13915, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Pitié Salpêtrière

Paris, 75651, France

Location

Clinique Belledonne

Saint-Martin-d'Hères, 38400, France

Location

CHU de Saint-Etienne, Hôpital Nord

Saint-Priest-en-Jarez, 42270, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Clinique du Tonkin

Villeurbanne, 69626, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Dissection, Thoracic Aorta; Penetrating Atherosclerotic Ulcer; Aortic Diseases

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Dissection; Dissection, Blood Vessel; Acute Aortic Syndrome; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Hervé Rousseau, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 24, 2013
• Study Start: March 23, 2013
• Primary Completion: June 21, 2021
• Study Completion: December 9, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (17)