GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry

W.L. Gore & Associates

Status: Completed

Conditions: Penetrating Ulcer; Aortic Aneurysm, Thoracic; Descending Thoracic Aortic Dissection; Aorta Thoracic; Traumatic Rupture; Aortic Diseases

Treatments: Device: GORE® TAG® Thoracic Endoprostheses

Study type: Observational

Funder types: Industry

Identifiers

NCT02266342

FPR12-03

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design