Clinical trial NCT01775046: Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases (VALIANT CAPTIVIA France)
Official title: Post-market Study on Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Thoracic
Descending Thoracic Aortic Dissection
Penetrating Ulcer
Aorta Thoracic; Traumatic Rupture
Aortic Diseases
Keywords: Valiant
Captivia
Stent Graft
Thoracic
Aortic
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2013-01-24
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with a disease of descending thoracic aorta (DTA) and requiring endovascular treatment with Stent Graft.

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.

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.

Primary outcomes:
measure: All-cause mortality
timeFrame: 5 years
Secondary outcomes:
measure: Exclusion of aneurysm, penetrating aortic ulcer (PAU), false lumen or rupture site
timeFrame: Through 5 years
measure: Major Adverse Events
timeFrame: Through 5 years
measure: Conversion to open repair
timeFrame: Through 5 years
measure: Endovascular or surgical secondary procedures
timeFrame: Through 5 years
measure: Adverse device effects
timeFrame: Through 5 years
measure: Thoracic disease-related mortality
timeFrame: Through 5 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie, Hôpital Sud
city: Bordeaux
country: France
facility: CHU de Bordeaux, Groupe Hospitalier Pellegrin
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: La Tronche
country: France
facility: CHU Grenoble, Hôpital A. Michallon
city: Le Chesnay
country: France
facility: Hôpital Privé de Parly 2
city: Le Plessis-Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
city: Limoges
country: France
facility: CHU de Limoges
city: Marseille
country: France
facility: Hôpital Privé Vert Coteau
city: Marseille
country: France
facility: Hôpital de la Timone
city: Marseille
country: France
facility: Hôpital Nord
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Saint Priest en Jarez
country: France
facility: CHU de Saint-Etienne, Hôpital Nord
city: Saint-Martin-d'Hères
country: France
facility: Clinique Belledonne
city: Toulouse
country: France
facility: CHU Rangueil
city: Toulouse
country: France
facility: Clinique Pasteur
city: Villeurbanne
country: France
facility: Clinique du Tonkin
Study officials:
affiliation: CHU Rangueil, 1 Avenue Jean Poulhes, TSA 50 032, 31059 TOULOUSE Cedex 9, FRANCE
name: Hervé Rousseau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: