N/A N=181

GORE® EXCLUDER® Endoprosthesis French Mandatory Registry

Abdominal Aortic Aneurysm

Bottom Line

View on ClinicalTrials.gov: NCT02308839 ↗

Enrolled (actual)

181

Serious AEs

38.1%

Results posted

May 2020

Primary outcome: Primary: Percentage of Participants Survived at 5 Years — 76 Percentage of participants alive

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: GORE® EXCLUDER® Endoprosthesis (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: W.L.Gore & Associates
Primary completion: Sep 2018

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	—

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).

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).

View full record on ClinicalTrials.gov →

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.