Clinical Trial: STARgraft (10401) Randomized Controlled Trial

U.S., May 1 -- ClinicalTrials.gov registry received information related to the study (NCT07557862) titled 'STARgraft (10401) Randomized Controlled Trial' on April 22.

Brief Summary: This is a multi-site, single-blind with parallel group, randomized controlled trial of Healionics STARgraft (10401) vascular graft for hemodialysis access compared with a market-leading commercially available ePTFE vascular graft (Gore Propaten Vascular Graft).

Study Start Date: July, 2026

Study Type: INTERVENTIONAL

Condition: End Stage Renal Disease (ESRD)

Intervention: DEVICE: STARgraft (10401)

Device: STARgraft (10401) Surgical implantation of STARgraft (10401) for Hemodialysis in the upper forearm.

DEVICE: Gore Propaten

Device: Gore Propaten Surgic...