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STARgraft (10401) Pilot

NCT07555717 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-29

No results posted yet for this study

Summary

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.

Conditions

  • End Stage Kidney Disease (ESRD)

Interventions

DEVICE

STARgraft (10401)

Participants will be implanted with 6mm diameter STARgraft (10401) grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.

Sponsors & Collaborators

  • Healionics Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-29
Primary Completion
2026-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • Paraguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07555717 on ClinicalTrials.gov