NCT04783779

Evaluation of STARgraft-2 for Hemodialysis Access

Completed NA Last updated 28 February 2024

What this trial tests

NA trial testing Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access in End Stage Renal Disease in 24 participants. Completed in 31 October 2023.

Timeline

16 February 2021

Primary endpoint
1 June 2022

31 October 2023

Quick facts

Lead sponsor	Healionics Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	16 February 2021
Primary completion	1 June 2022
Estimated completion	31 October 2023
Sites	1 location across Paraguay

Drugs / interventions tested

• Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access

Conditions studied

• End Stage Renal Disease — all drugs for End Stage Renal Disease →

Sponsor

Healionics Corporation

Who can join

18 and older, any sex, with End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Medical Applications of Porous Biomaterials: Features of Porosity and Tissue-Specific Implications for Biocompatibility.
   Hernandez JL, Woodrow KA. · · 2022 · cited 109× · PMID 35137550 · DOI 10.1002/adhm.202102087