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

This study is currently recruiting participants.
Verified April 2013 by Medtronic Endovascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01775046
First received: January 21, 2013
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 160
Study Start Date: March 2013
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (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 Janauary 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775046

Contacts
Contact: Manuel Girard +33474370312 manuel.girard@medtronic.com
Contact: Kristel Wittebols +31433566580 kristel.wittebols@medtronic.com

Locations
France
Centre Chirurgical Marie Lannelongue Recruiting
Le Plessis-Robinson, France, 92350
Contact: Ryad Bourkaïb, MD     +33(0)1 40 94 86 41     rbourkaib@gmail.com    
Principal Investigator: Ryad Bourkaïb, MD            
Sub-Investigator: Claude Angel, MD            
Sub-Investigator: Olivier Planché, MD            
Sub-Investigator: Philippe Brenot, MD            
Sub-Investigator: Jean-Yves Riou, MD            
Clinique Belledonne Not yet recruiting
Saint-Martin-d'Hères, France, 38400
Contact: Stéphane Chabert, MD     +33 (0)4 38 38 02 02     stephanechabert@cccva.fr    
Principal Investigator: Stéphane Chabert, MD            
Sub-Investigator: Issam Farah, MD            
CHU Rangueil Recruiting
Toulouse, France, 31059
Contact: Hervé Rousseau     +33 (0)5 61 32 28 81     rousseau.h@chu-toulouse.fr    
Principal Investigator: Hervé Rousseau, MD, PhD            
Sub-Investigator: Christophe Lions, MD            
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: April 15, 2013
Health Authority: France: Haute Autorité de Santé Transparency Commission

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

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Diseases
Ulcer
Aortic Aneurysm, Thoracic
 Rupture
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013