GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry

W.L.Gore & Associates154 enrolled

Overview

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.

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

154

Conditions

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

Interventions

GORE® TAG® Thoracic EndoprosthesesDEVICE

Endovascular therapy to treat thoracic disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Hopitaux Universitaire de Strasbourg

Strasbourg, France

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

Time frame: 5 years

Number of Subjects With Neurological Complications

Time frame: 5 years

Number of Subjects With Cardiac, Renal, and Pulmonary Complications

Time frame: 5 years

Number of Subjects With Device-related Complications

Time frame: 5 years

Number of Subjects With Surgical Conversion

Time frame: 5 years

Number of Subjects With Secondary Procedures

Time frame: 5 years

Number of Subjects With Disease Related Mortality

Time frame: 5 years

Data from ClinicalTrials.gov

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