Hemodialysis Clinical Trial
Official title:
GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis.
The primary effectiveness hypothesis is to demonstrate that the GORE VIABAHN® Endoprosthesis
with PROPATEN Bioactive Surface will extend the period of target lesion primary patency as
compared to PTA.
The primary safety hypothesis is to demonstrate that the proportion of subjects remaining
free from major device, procedure, and treatment site-related adverse events through 30 days
post-procedure in the GORE® VIABAHN® Device group is not inferior to that of the PTA group.
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