Compares a new STARgraft vascular graft with Gore Propaten for dialysis access
Tests a new STARgraft graft against a standard graft in adults with kidney failure.
Plain-language title generated from the registry record
Registry title: Multi-Site STARgraft (10401) Trial
Key facts
- Where
- Brasília, Florianópolis, Recife, Rio de Janeiro, and Salvador, BrazilSee the 5 sites
Where in Brazil
- Afya Hospital Dia, Brasília.Brasília, BrazilNo longer taking part
- Hospital Baia SulFlorianópolis, BrazilNo longer taking part
- Royal Portuguese Beneficent Hospital in PernambucoRecife, BrazilNo longer taking part
- Pedro Ernesto University HospitalRio de Janeiro, BrazilNo longer taking part
- Hospital Ana NerySalvador, BrazilNo longer taking part
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
- NCT07557862
- Record updated
- 13 August 2026
- Original description
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).Read full original descriptionShow less
Multi-Site Randomized Controlled Trial of STARgraft (10401) Vascular Graft for Hemodialysis Access
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).
Inclusion: 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; 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 (PD) 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 (HIT); Known allergic reaction to silicone; 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.