Testing a new artificial blood vessel graft for dialysis access in kidney failure
Tests the STARgraft vascular graft for dialysis access in adults with kidney failure.
Plain-language title generated from the registry record
Registry title: STARgraft (10401) Pilot
Key facts
- Where
- Asunción, ParaguaySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with end stage kidney disease who need a new graft in the upper arm for hemodialysis. It tests the STARgraft (10401) over 6 months.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- End stage kidney disease. The person needs a new AV graft in the upper arm and is judged to need dialysis within 2 months. Life expectancy of at least 2 years.
- Earlier treatment
- A person with peritoneal dialysis within the last 2 months cannot join. A failed access at a different body location is allowed.
- Biomarker or test result
- Axillary vein about 7 mm or wider. Brachial artery about 4 mm or wider. Cardiac output ≥ 3.5 l/min, pulmonary artery pressure ≤ 50 mmHg, ejection fraction ≥ 40%. Systolic blood pressure 120 mmHg or higher. No narrowing of the central veins.
Main reasons for not taking part
- Pregnancy
- Central venous catheter on the same side as the planned graft
- BMI above 40
- Bleeding or clotting disorders, or immunodeficiency syndrome
- Infection within 8 weeks before the graft, or severe heart disease
This trial only enrols participants on dialysis. The registry sentence this rests on: The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft.
Read by machine on 9 November 2026.
Where in Paraguay
- Italian HospitalAsunción, ParaguayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Healionics Corporation
- Trial code
- NCT07555717
- Record updated
- 29 April 2026
- Original description
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft (10401) hemodialysis access graft.Read full original descriptionShow less
STARgraft Vascular Graft 10401 for Hemodialysis Access Pilot
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.
Inclusion: 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; Brachial artery approximately 4 mm in diameter or greater; Acceptable cardiac risk level (cardiac output ≥ 3.5 l/min, pulmonary artery pressure ≤ 50 mmHg, and ejection fraction ≥ 40%); Systolic blood pressure equal to or greater than 120 mmHg; Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram.
Exclusion: Previous history of Peritoneal Dialysis treatment within the last 2 months; Central venous catheter located on same side as intended implant location; Medically confirmed stenosis or compromised valves in the veins downstream of the implant site; Inadequate arterial flow or pressure proximal to the implant site; Currently participating in another investigational drug or device trial which may clinically interfere with any endpoints of this trial; Confirmed or suspected bacterial, viral or parasitic infection within 8 weeks prior to graft implant, or ongoing symptoms; Immunodeficiency syndrome; History of hypercoagulation or bleeding disorders; History of heparin-induced thrombocytopenia syndrome; Known allergic reaction to silicone, or untreatable allergy to imaging contrast materials; Uncontrolled or poorly controlled diabetes; History or evidence of severe cardiac disease; Any other condition which, in the judgment of the Investigator, would preclude adequate evaluation or impact patient safety or trial conduct; Elevated platelet count > 1 million per microliter of blood; Unable or unlikely to comply with trial protocol and/or follow-up; Pregnancy; Clinical morbid obesity (BMI > 40); Anatomical limitations, including issues discovered intraoperatively during vessel exposure; Fever greater than 38°C.