GORE® EXCLUDER® Endoprosthesis French Mandatory Registry

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Study of the GORE® EXCLUDER® Endoprosthesis in the Treatment of Infra-renal Abdominal Aortic Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308839
• Other study ID #: FPR12-02
• Status: Completed
• Start date: July 2012
• Est. completion date: October 5, 2018

Study information

• Verified date: May 2020
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: October 5, 2018
• Est. primary completion date: September 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• GORE® EXCLUDER® Endoprosthesis
Endovascular therapy to treat abdominal aortic aneurysms

Locations

Country	Name	City	State
France	Centre Hospitalier de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

France, 

Outcome

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