NCT05729620Active, not recruiting
Evaluation of STARgraft-3 for Hemodialysis
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection. This study is an extension from prior studies with STARgraft AV (NCT03916731) and STARgraft-2 (NCT04783779) investigational devices. A previous study also included control implants of commercially available standard ePTFE grafts approved for the same use. 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-3 compared to the ePTFE controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year. Estimated enrollment is 15 subjects in this study.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 6 Feb 2023
- Start date
- Nov 2022
- Primary completion date
- Feb 2024
- Lead sponsor
- Healionics Corporation
- Diseases
- Chronic kidney disease
- NCT number
- NCT05729620
What you commit to
- Study type: Interventional
- Planned participants: 21
- From Nov 2022 to the primary completion date, Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of bacterial infection within 8 weeks prior to graft implantation.
- Medically confirmed stenosis of the veins downstream of the implant site.
- Inadequate arterial flow or pressure proximal to the implant site.
- Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial.
- Prior allergic reaction to silicone.
- Confirmed or suspected COVID-19 infection within 8 weeks prior to graft implant, or ongoing COVID-19 symptoms.
Other illness
- Immunodeficiency syndrome.
- History of hypercoagulation or bleeding disorders.
- History of heparin-induced thrombocytopenia syndrome (HIT).
Lab values
- Elevated platelet count \> 1 million per microliter of blood.
Other
- Unable or unlikely to comply with trial protocol and/or follow-up.
- Pregnancy.
- Clinically morbid obesity.
- Anatomical limitations.
- Fever greater than 38°C.
Who the study is looking for
- Male or female, \> 18 years or age.
- Patient has given informed consent to participate in the trial.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Able to effectively communicate with study personnel.
- Candidate for a new arterio-venous graft placed in the upper arm.
- Life expectancy judged to be at least 2 years.
- Axillary vein of greater than or equal to 7 mm in diameter.
- Brachial artery of greater than or equal to 4 mm in diameter.
- Acceptable cardiac risk level (Cardiac Output ≥ 3.5 L/min, Pulmonary Artery Pressure ≤ 50 mmHg, 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Italian Hospital Coordinator of this site? Confirm its status | Asunción | Paraguay | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.