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Completed

NCT Number: NCT02266342

GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry

This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta.

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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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

About this study

Endovascular therapy to treat thoracic disease seems to provide a plausible benefit compared to surgery in terms of operative mortality and severe morbidity. The French National Health Authority (HAS) requires a 5-year follow-up as part of the renewal of reimbursement for these endoprostheses in order to collect long-term follow-up data under real-life conditions of use.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient where a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis is implanted (successfully or not) for the treatment of disease of the descending thoracic aorta.
  • Patient who had previously consented to the collection and processing of personal medical data.
  • Patient older than 18 years at the time of treatment.

Exclusion criteria

  • Patients who have already received treatment with a thoracic endoprosthesis other than the GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis and for whom 'revision' or reintervention is required.
  • Patients whose clinical follow-up is not possible (i.e. patients who cannot return for control visits because they live abroad).

Treatment and study plan

GORE® TAG® Thoracic Endoprostheses

Device

Endovascular therapy to treat thoracic disease

Other names: Conformable GORE® TAG® Thoracic Endoprostheses

Primary outcomes

  1. Number of Subjects With All-cause Mortality (Long-term)

    Time frame: 5 years

Secondary outcomes

  1. Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture

    Time frame: 5 years

  2. Number of Subjects With Neurological Complications

    Time frame: 5 years

  3. Number of Subjects With Cardiac, Renal, and Pulmonary Complications

    Time frame: 5 years

  4. Number of Subjects With Device-related Complications

    Time frame: 5 years

  5. Number of Subjects With Surgical Conversion

    Time frame: 5 years

  6. Number of Subjects With Secondary Procedures

    Time frame: 5 years

  7. Number of Subjects With Disease Related Mortality

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

Evaluation on the Treatment of Diseases of the Thoracic Aorta With the Thoracic Endoprosthesis GORE® TAG®

Important dates

Study start
2014
Primary completion
2021
Study completion
2022
First posted
Oct 17, 2014
Registry last updated
Apr 19, 2024

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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