Pilot Study of the STARgraft 10401 Device for Hemodialysis Access in Adults with End Stage Kidney Disease

What this Trial Is About

Researchers are evaluating the safety and performance of the STARgraft 10401 hemodialysis access graft in patients with End Stage Renal Disease ESRD who require hemodialysis through a prosthetic vascular graft. This single-site, prospective, single-arm study compares the investigational STARgraft with prior ePTFE controls and published data over a 6-month period, with potential additional data collection extending to 36 months post-implantation. Participants will receive a 6mm diameter STARgraft 10401 device implanted as an upper arm Brachial Artery to Axillary Vein shunt to provide vascular access for hemodialysis. The study focuses on evaluating the devices effectiveness and safety within this treatment setup, with no comparator arm in this single-arm design. During the study, participants will be monitored for primary unassisted patency and serious device-related adverse events at 6 months, along with longer-term assessments up to 36 months including assisted patency, graft infections, major events, and additional safety measures. These evaluations involve clinical follow-up visits and safety monitoring, with total participation potentially lasting up to three years after graft implantation.

STARgraft (10401) Pilot