Evaluation of STARgraft-2 for Hemodialysis Access

Status Completed

Clinical Trial Summary

This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection. This study is an extension from a prior First in Human (FIH) study (NCT03916731) with the STARgraft AV investigational device. That study also included control implants of commercially available standard ePTFE grafts approved for the same use. The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to: 1. Evaluate the performance of the investigational STARgraft-2 compared to the ePTFE controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year. 2. Verify safety of the STARgraft-2 multilayer construction in extended dialysis vascular access use. It is intended to enroll 25 subjects in this study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04783779
Study type	Interventional
Source	Healionics Corporation
Contact
Status	Completed
Phase	N/A
Start date	February 16, 2021
Completion date	October 31, 2023

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