GORE® EXCLUDER® Endoprosthesis French Mandatory Registry

Completed

• Conditions: Abdominal Aortic Aneurysm

• Registration Number: NCT02308839
• Lead Sponsor: W.L.Gore & Associates

Brief 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).

Detailed Description

The use of abdominal aortic endoprostheses makes the treatment of infra-renal abdominal aortic aneurysms possible, with implantation via the femoral artery, thus avoiding a very invasive surgical procedure. The French National Authority for Health requires a 5-year follow-up as part of the renewal for reimbursement for these endoprostheses.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2014-11-21
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-04
• Primary Completion: 2018-09-26
• Study Completion: 2018-10-05
• Results First Submitted: 2020-04-14
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-07
• Last Update Submitted: 2020-05-07
• Results First Posted: 2020-05-22
• Last Update Posted: 2020-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Survived at 5 Years	5 years	Kaplan-Meier estimate of participant survival at 5 years

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Free From Aneurysm Diameter Growth at 5 Years	5 years	Kaplan-Meier estimate of participant freedom from aneurysm diameter growth at 5 years
Percentage of Participants Free From Surgical Conversion at Procedure	Index Procedure	Participant freedom from surgical conversion at procedure
Percentage of Participants Free From Migration at 5 Years	5 years	Kaplan-Meier estimate of participant freedom from migration at 5 years
Percentage of Participants Free From Endoleak at 5 Years	5 years	Kaplan-Meier estimate of participant freedom from endoleak (Type I, II and III) at 5 years
Percentage of Participants Free From Aneurysm Related Mortality at 5 Years	5 years	Kaplan-Meier estimate of participant freedom from aneurysm related mortality at 5 years
Percentage of Participants Free From Endovascular or Surgical Re-intervention at 5 Years	5 years	Kaplan-Meier estimate of participant freedom from endovascular or surgical re-intervention at 5 years

Trial Locations

Locations (1)

Centre Hospitalier de Dijon; 🇫🇷 Dijon, France