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

W.L.Gore & Associates1 site in 1 country154 target enrollmentOctober 2014

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Aneurysm, Thoracic
Sponsor: W.L.Gore & Associates
Enrollment: 154
Locations: 1
Primary Endpoint: Number of Subjects With All-cause Mortality (Long-term)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

April 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

W.L.Gore & Associates

Responsible Party

Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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

Time Frame: 5 years

Secondary Outcomes

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)