GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry

Completed

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

• Registration Number: NCT02266342
• Lead Sponsor: W.L.Gore & Associates

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-17
• Primary Completion: 2021-12
• Study Completion: 2022-04
• Results First Submitted: 2022-12-13
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-07
• Last Update Submitted: 2023-11-07
• Results First Posted: 2024-04-19
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Subjects With All-cause Mortality (Long-term)	5 years

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture	5 years
Number of Subjects With Cardiac, Renal, and Pulmonary Complications	5 years
Number of Subjects With Device-related Complications	5 years
Number of Subjects With Disease Related Mortality	5 years
Number of Subjects With Neurological Complications	5 years
Number of Subjects With Surgical Conversion	5 years
Number of Subjects With Secondary Procedures	5 years

Trial Locations

Locations (1)

Hopitaux Universitaire de Strasbourg; 🇫🇷 Strasbourg, France