N/A
Completed N=181
GORE® EXCLUDER® Endoprosthesis French Mandatory Registry
Source: ClinicalTrials.gov NCT02308839 ↗Enrolled (actual)
181
Serious AEs
38.1%
Results posted
May 2020
Primary outcomePrimary: Percentage of Participants Survived at 5 Years — 76 Percentage of participants alive
Summary
This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® Excluder® Endoprosthesis in the treatment of infra-renal Abdominal Aortic Aneurysms (AAA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Survived at 5 Years |
76 | — |
| SECONDARY Percentage of Participants Free From Endoleak at 5 Years |
72 | — |
| SECONDARY Percentage of Participants Free From Migration at 5 Years |
100 | — |
| SECONDARY Percentage of Participants Free From Aneurysm Diameter Growth at 5 Years |
77 | — |
| SECONDARY Percentage of Participants Free From Aneurysm Related Mortality at 5 Years |
99 | — |
| SECONDARY Percentage of Participants Free From Endovascular or Surgical Re-intervention at 5 Years |
75 | — |
| SECONDARY Percentage of Participants Free From Surgical Conversion at Procedure |
100 | — |
Eligibility Criteria
Inclusion Criteria
- Any patients requiring abdominal aortic stenting for the treatment of an unruptured infra-renal aortic abdominal aneurysm.
Exclusion Criteria
- Patients whose clinical follow-up is not possible, i.eg, patient who cannot return for control visits (e.g. patients living abroad).
Data sourced from ClinicalTrials.gov (NCT02308839). 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.