GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Diseases; Aortic Aneurysm, Thoracic; Penetrating Ulcer; Descending Thoracic Aortic Dissection; Aorta Thoracic; Traumatic Rupture
• Intervention / Treatment: Device: GORE® TAG® Thoracic Endoprostheses

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 Type: Observational
• Enrollment (Actual): 154

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Hopitaux Universitaire de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with a disease of the descending thoracic aorta, requiring treatment with a thoracic endoprosthesis.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Subjects With All-cause Mortality (Long-term)	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture	5 years
Number of Subjects With Neurological Complications	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 Surgical Conversion	5 years
Number of Subjects With Secondary Procedures	5 years
Number of Subjects With Disease Related Mortality	5 years

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Nabil Chakfé, Prof, Hopitaux Universitaire de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: October 10, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (Estimated): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Wounds and Injuries; Dissection, Blood Vessel; Acute Aortic Syndrome; Rupture; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aortic Diseases; Aortic Dissection; Penetrating Atherosclerotic Ulcer; Dissection, Thoracic Aorta
• Other Study ID Numbers: FPR12-03