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Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

W.L.Gore & Associates · 2010
ClinicalTrials.gov · Datasets · License: Public Domain · 2010
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end-stage-renal-disease
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). \> \>\> \> \>\> 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. \> \>\> \> \>\> Subjects will be selected from up to 20 Investigational Sites.
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