GORE® EXCLUDER® Endoprosthesis French Mandatory Registry

May 7, 2020 updated by: W.L.Gore & Associates

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

181

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21034
        • Centre hospitalier de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients requiring treatemtn with an endoprosthesis for the treatment of an unruptured infra-renal aortic abdominal aneurysm.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Survived at 5 Years
Time Frame: 5 years
Kaplan-Meier estimate of participant survival at 5 years
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Investigators

  • Principal Investigator: Eric Steinmetz, Prof, Centre Hospitalier Universitaire du Bocage

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Actual)

September 26, 2018

Study Completion (Actual)

October 5, 2018

Study Registration Dates

First Submitted

November 21, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

May 22, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPR12-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abdominal Aortic Aneurysm

Clinical Trials on GORE® EXCLUDER® Endoprosthesis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe