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

Sponsor

Medtronic Cardiovascular (Industry)

Overall Status

Completed

CT.gov ID

NCT01775046

Collaborator

(none)

160

Enrollment

Locations

104.6

Actual Duration (Months)

9.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Thoracic Descending Thoracic Aortic Dissection Penetrating Ulcer Aorta Thoracic; Traumatic Rupture Aortic Diseases	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 Design

Study Type:

Observational

Actual Enrollment :

160 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Post-market Study on Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases

Actual Study Start Date :

Mar 23, 2013

Actual Primary Completion Date :

Jun 21, 2021

Actual Study Completion Date :

Dec 9, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

All-cause mortality [5 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Amiens Picardie, Hôpital Sud	Amiens	France	80054
2	CHU de Bordeaux, Groupe Hospitalier Pellegrin	Bordeaux	France	33000
3	Hôpital Henri Mondor	Créteil	France	94010
4	CHU Grenoble, Hôpital A. Michallon	La Tronche	France	38700
5	Hôpital Privé de Parly 2	Le Chesnay	France	78150
6	Centre Chirurgical Marie Lannelongue	Le Plessis-Robinson	France	92350
7	CHU de Limoges	Limoges	France	87042
8	Hôpital Privé Vert Coteau	Marseille	France	13012
9	Hôpital de la Timone	Marseille	France	13385
10	Hôpital Nord	Marseille	France	13915
11	Hôpital Européen Georges Pompidou	Paris	France	75015
12	Hôpital Pitié Salpêtrière	Paris	France	75651
13	CHU de Saint-Etienne, Hôpital Nord	Saint Priest en Jarez	France	42270
14	Clinique Belledonne	Saint-Martin-d'Hères	France	38400
15	CHU Rangueil	Toulouse	France	31059
16	Clinique Pasteur	Toulouse	France	31076
17	Clinique du Tonkin	Villeurbanne	France	69626