Not Yet RecruitingNot Applicable

Multi-Site STARgraft (10401) Trial

Colombia75 participantsStarted 2026-07

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease (ESRD) and intends to use the Vascular Graft device for arteriovenous (AV) access.
✓. The patient is currently on hemodialysis or intended to begin hemodialysis within 60 days following placement of the device.
✓. Adult patients, 18 years or older.
✓. Patient has given informed consent to participate in the trial.
✓. Stated willingness to comply with all trial procedures and availability for the duration of the trial.
✓. Able to effectively communicate with trial personnel.
✓. Life expectancy judged to be at least 2 years with consideration of patient frailty.
✓. Axillary vein approximately 7 mm in diameter or greater.

Exclusion criteria

✕. Unable or unlikely to comply with trial protocol and/or follow-up.
✕. Pregnancy.
✕. Previous history of peritoneal dialysis (PD) treatment within the last 2 months
✕. Central venous catheter located on same side as intended implant location.
✕. Clinical morbid obesity (BMI \> 40).
✕. Anatomical limitations, including issues discovered intraoperatively during vessel exposure.
✕. Immunodeficiency syndrome.
✕. History of hypercoagulation or bleeding disorders.

What they're measuring

Safety: Subjects with Major Adverse Event

Timeframe: 6 months

Effectiveness: Primary Unassisted Patency

Timeframe: 6 months

Trial details

NCT IDNCT07557862

SponsorHealionics Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Ashleigh Cooper

206-432-9060 ashleigh@healionics.com

View on ClinicalTrials.gov More End Stage Renal Disease (ESRD) trials