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GORE® EXCLUDER® Endoprosthesis French Mandatory Registry

NCT ID: NCT02308839

Last Updated: 2020-05-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

181 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2018-10-05

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).

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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.

Conditions

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Abdominal Aortic Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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GORE® EXCLUDER® Endoprosthesis

Endovascular therapy to treat abdominal aortic aneurysms

Intervention Type DEVICE

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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W.L.Gore & Associates

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Steinmetz, Prof

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire du Bocage

Locations

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Centre Hospitalier de Dijon

Dijon, , France

Site Status

Countries

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France

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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FPR12-02

Identifier Type: -

Identifier Source: org_study_id

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