Aortic Diseases Clinical Trial
Official title:
Evaluation on the Treatment of Diseases of the Thoracic Aorta With the Thoracic Endoprosthesis GORE® TAG®
NCT number | NCT02266342 |
Other study ID # | FPR12-03 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | April 2022 |
Verified date | November 2023 |
Source | W.L.Gore & Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 154 |
Est. completion date | April 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
France | Hopitaux Universitaire de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
W.L.Gore & Associates |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With All-cause Mortality (Long-term) | 5 years | ||
Secondary | Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture | 5 years | ||
Secondary | Number of Subjects With Neurological Complications | 5 years | ||
Secondary | Number of Subjects With Cardiac, Renal, and Pulmonary Complications | 5 years | ||
Secondary | Number of Subjects With Device-related Complications | 5 years | ||
Secondary | Number of Subjects With Surgical Conversion | 5 years | ||
Secondary | Number of Subjects With Secondary Procedures | 5 years | ||
Secondary | Number of Subjects With Disease Related Mortality | 5 years |
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