End Stage Renal Disease Clinical Trial
Official title:
Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL, AVG 08-06)
This study is a prospective, non-randomized, multi-center evaluation of the performance of
the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal
Disease (ESRD), who are either currently receiving or expected to require hemodialysis
through a prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6
month cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other
arteriovenous grafts (AVGs).
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> A total of 138 Subjects will be enrolled. Once the study procedure has been successfully
completed, cannulation may occur at any time at the Investigator's discretion.
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> Subjects will be selected from up to 20 Investigational Sites.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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