Actively Recruiting
STARgraft (10401) Pilot
Led by Healionics Corporation · Updated on 2026-04-29
20
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
STARgraft (10401) Pilot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients, 18 years or older
- Patient has given informed consent to participate in the trial
- Willingness to comply with all trial procedures and availability for the duration of the trial
- Able to effectively communicate with trial personnel
- Diagnosed with end stage renal disease
- Candidate for a new upper arm arteriovenous graft and expected to need dialysis within 2 months; may have failed access at a different site
- Life expectancy of at least 2 years considering 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, ejection fraction ≥ 40%)
- Systolic blood pressure ≥ 120 mmHg
- No central venous stenosis downstream from implant site confirmed by ultrasound or venogram
You will not qualify if you...
- Unable or unlikely to comply with trial protocol and follow-up
- Pregnancy
- Previous history of peritoneal dialysis treatment within the last 2 months
- Central venous catheter on the same side as intended implant location
- Clinical morbid obesity (BMI > 40)
- Anatomical limitations including issues discovered during vessel exposure
- Immunodeficiency syndrome
- History of hypercoagulation or bleeding disorders
- Elevated platelet count > 1 million per microliter of blood
- History of heparin-induced thrombocytopenia syndrome
- Medically confirmed stenosis or compromised valves in veins downstream of implant site
- Inadequate arterial flow or pressure proximal to implant site
- Currently participating in another investigational drug or device trial that may interfere with endpoints
- Fever greater than 38°C
- Known allergic reaction to silicone or untreatable allergy to imaging contrast materials
- Confirmed or suspected bacterial, viral, or parasitic infection within 8 weeks prior to graft implant or ongoing symptoms
- Uncontrolled or poorly controlled diabetes
- History or evidence of severe cardiac disease
- Any other condition that could preclude adequate evaluation or impact patient safety or trial conduct
AI-Screening
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Trial Site Locations
Total: 1 location
1
Italian Hospital
Asunción, Paraguay
Actively Recruiting
Research Team
A
Ashleigh Cooper
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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