GORE® EXCLUDER® Endoprosthesis French Mandatory Registry
Study of the GORE® EXCLUDER® Endoprosthesis in the Treatment of Infra-renal Abdominal Aortic Aneurysms
1 other identifier
observational
181
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 21, 2014
CompletedFirst Posted
Study publicly available on registry
December 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2018
CompletedResults Posted
Study results publicly available
May 22, 2020
CompletedMay 22, 2020
May 1, 2020
6.2 years
November 21, 2014
April 14, 2020
May 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Survived at 5 Years
Kaplan-Meier estimate of participant survival at 5 years
5 years
Secondary Outcomes (6)
Percentage of Participants Free From Endoleak at 5 Years
5 years
Percentage of Participants Free From Migration at 5 Years
5 years
Percentage of Participants Free From Aneurysm Diameter Growth at 5 Years
5 years
Percentage of Participants Free From Aneurysm Related Mortality at 5 Years
5 years
Percentage of Participants Free From Endovascular or Surgical Re-intervention at 5 Years
5 years
- +1 more secondary outcomes
Interventions
Endovascular therapy to treat abdominal aortic aneurysms
Eligibility Criteria
Patients requiring treatemtn with an endoprosthesis for the treatment of an unruptured infra-renal aortic abdominal aneurysm.
You may qualify if:
- Any patients requiring abdominal aortic stenting for the treatment of an unruptured infra-renal aortic abdominal aneurysm.
You may not qualify if:
- Patients whose clinical follow-up is not possible, i.eg, patient who cannot return for control visits (e.g. patients living abroad).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier de Dijon
Dijon, 21034, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Abe Letter
- Organization
- W.L. Gore & Associates
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Steinmetz, Prof
Centre Hospitalier Universitaire du Bocage
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2014
First Posted
December 4, 2014
Study Start
July 1, 2012
Primary Completion
September 26, 2018
Study Completion
October 5, 2018
Last Updated
May 22, 2020
Results First Posted
May 22, 2020
Record last verified: 2020-05