GORE® EXCLUDER® Endoprosthesis French Mandatory Registry

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: GORE® EXCLUDER® Endoprosthesis


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GORE® EXCLUDER® Endoprosthesis|Endovascular therapy to treat abdominal aortic aneurysms|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Survived at 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 | 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 | Kaplan-Meier estimate of participant freedom from migration at 5 years | 5 years | 
| 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 | 
| 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 | 
| 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 | 
| Percentage of Participants Free From Surgical Conversion at Procedure | Participant freedom from surgical conversion at procedure | Index Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aorta, Aneurysm, Abdominal