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NCT Number: NCT01775046

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

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.

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Key information

Conditions

Aortic Aneurysm, Thoracic Acute Aortic Syndrome Aneurysm Aorta Thoracic; Traumatic Rupture Aortic Aneurysm Aortic Diseases Aortic Dissection Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Descending Thoracic Aortic Dissection Dissection, Blood Vessel Dissection, Thoracic Aorta Penetrating Atherosclerotic Ulcer Penetrating Ulcer Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens Picardie, Hôpital Sud, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DTA patients (Valiant)

Device

Valiant Thoracic Stent Graft Implantation

Other names: TEVAR

Primary outcomes

  1. All-cause mortality

    Time frame: 5 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Jan 24, 2013
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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