STARgraft (10401) Pilot (NCT07555717) | Clinical Trial Compass
RecruitingNot Applicable
STARgraft (10401) Pilot
Paraguay20 participantsStarted 2026-01-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Indicated patient population (end stage renal disease).
✓. Candidate for a new AV graft placed in the upper arm and judged to need dialysis within 2 months. Patient may have a failed access at a different anatomical location.
✓. 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 treatment within the last 2 months
✕. Central venous catheter located on same side as intended implant location.