N/A
Completed N=154
GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry
Aortic Aneurysm, Thoracic · Descending Thoracic Aortic Dissection · Aortic diseases · Aorta Thoracic; Traumatic Rupture
Source: ClinicalTrials.gov NCT02266342 ↗
Enrolled (actual)
154
Serious AEs
51.3%
Results posted
Apr 2024
Primary outcomePrimary: Number of Subjects With All-cause Mortality (Long-term) — 31 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With All-cause Mortality (Long-term) |
31 | — |
| SECONDARY Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture |
50 | — |
| SECONDARY Number of Subjects With Neurological Complications |
13 | — |
| SECONDARY Number of Subjects With Cardiac, Renal, and Pulmonary Complications |
32 | — |
| SECONDARY Number of Subjects With Device-related Complications |
8 | — |
| SECONDARY Number of Subjects With Surgical Conversion |
— | — |
| SECONDARY Number of Subjects With Secondary Procedures |
27 | — |
| SECONDARY Number of Subjects With Disease Related Mortality |
5 | — |
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).
Data sourced from ClinicalTrials.gov (NCT02266342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.