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

Aortic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775046
• Other study ID #: MDTVCFRANCE001
• Status: Completed
• Start date: March 23, 2013
• Est. completion date: December 9, 2021

Study information

• Verified date: January 2022
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 9, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• DTA patients (Valiant)
Valiant Thoracic Stent Graft Implantation

Locations

Country	Name	City	State
France	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 de la Timone	Marseille
France	Hôpital Nord	Marseille
France	Hôpital Privé Vert Coteau	Marseille
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Pitié Salpêtrière	Paris
France	CHU de Saint-Etienne, Hôpital Nord	Saint Priest en Jarez
France	Clinique Belledonne	Saint-Martin-d'Hères
France	CHU Rangueil	Toulouse
France	Clinique Pasteur	Toulouse
France	Clinique du Tonkin	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

France, 

Outcome

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