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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01775046
Recruitment Status : Active, not recruiting
First Posted : January 24, 2013
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

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
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.

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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 : March 23, 2013
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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 Name: TEVAR




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Exclusion of aneurysm, penetrating aortic ulcer (PAU), false lumen or rupture site [ Time Frame: Through 5 years ]
  2. Major Adverse Events [ Time Frame: Through 5 years ]
    This includes respiratory, neurological, vascular, cardiac, renal, bleeding, visceral and infectious complications and any complication leading to death

  3. Conversion to open repair [ Time Frame: Through 5 years ]
  4. Endovascular or surgical secondary procedures [ Time Frame: Through 5 years ]
  5. Adverse device effects [ Time Frame: Through 5 years ]
  6. Thoracic disease-related mortality [ Time Frame: Through 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775046


Locations
Show Show 17 study locations
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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Principal Investigator: Hervé Rousseau, MD, PhD CHU Rangueil, 1 Avenue Jean Poulhes, TSA 50 032, 31059 TOULOUSE Cedex 9, FRANCE

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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01775046    
Other Study ID Numbers: MDTVCFRANCE001
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only multi center data will be available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medtronic Endovascular:
Valiant
Captivia
Stent Graft
Thoracic
Aortic
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Aortic Aneurysm
Aortic Diseases
Aortic Aneurysm, Thoracic
Rupture
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries