STARgraft (10401) Pilot

简要摘要

This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft (10401) hemodialysis access graft. The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to evaluate the performance of the investigational STARgraft (10401) compared to the ePTFE controls in a prior study (NCT03916731) and to published results, over a period of 6 months. Additional data out to 36 months post-implantation may be captured.