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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01775046
First received: January 21, 2013
Last updated: January 11, 2016
Last verified: January 2016
  Purpose
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 Intervention
Aortic Aneurysm, Thoracic
Descending Thoracic Aortic Dissection
Penetrating Ulcer
Aorta Thoracic; Traumatic Rupture
Aortic Diseases
Device: DTA patients (Valiant)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exclusion of aneurysm, penetrating aortic ulcer (PAU), false lumen or rupture site [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
  • Major Adverse Events [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
    This includes respiratory, neurological, vascular, cardiac, renal, bleeding, visceral and infectious complications and any complication leading to death

  • Conversion to open repair [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
  • Endovascular or surgical secondary procedures [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
  • Adverse device effects [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]
  • Thoracic disease-related mortality [ Time Frame: Through 5 years ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: March 2013
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: November 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: TEVAR

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects diagnosed with a disease of descending thoracic aorta (DTA) and requiring endovascular treatment with Stent Graft.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775046

Locations
France
CHU Amiens Picardie, Hôpital Sud
Amiens, France, 80054
CHU de Bordeaux, Groupe Hospitalier Pellegrin
Bordeaux, France, 33000
Hôpital Henri Mondor
Créteil, France, 94010
CHU Grenoble, Hôpital A. Michallon
La Tronche, France, 38700
Hôpital Privé de Parly 2
Le Chesnay, France, 78150
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, France, 92350
CHU de Limoges
Limoges, France, 87042
Clinique de la Sauvegarde
Lyon, France, 69009
Hôpital Nord
Marseille, France, 13915
Hôpital de la Timone
Marseille, France, 13385
Hôpital Privé Résidence du Parc
Marseille, France, 13010
Hôpital Européen Georges Pompidou
Paris, France, 75015
Hôpital Pitié Salpêtrière
Paris, France, 75651
CHU de Saint-Etienne, Hôpital Nord
Saint Priest en Jarez, France, 42270
Clinique Belledonne
Saint-Martin-d'Hères, France, 38400
CHU Rangueil
Toulouse, France, 31059
Clinique Pasteur
Toulouse, France, 31076
Clinique Saint-Joseph
Trélazé, France, 49800
Clinique du Tonkin
Villeurbanne, France, 69626
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Hervé Rousseau, MD, PhD CHU Rangueil, 1 Avenue Jean Poulhes, TSA 50 032, 31059 TOULOUSE Cedex 9, FRANCE
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01775046     History of Changes
Other Study ID Numbers: MDTVCFRANCE001 
Study First Received: January 21, 2013
Last Updated: January 11, 2016
Health Authority: France: Haute Autorité de Santé Transparency Commission

Keywords provided by Medtronic Endovascular:
Valiant
Captivia
Stent Graft
Thoracic
Aortic

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Aortic Diseases
Aneurysm
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 11, 2016