Actively Recruiting
STARgraft Vascular Graft 10401 for Hemodialysis Access Pilot Study
Led by Healionics Corporation · Updated on 2026-04-29
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the STARgraft (10401) hemodialysis access graft in patients with End Stage Renal Disease (ESRD) who require hemodialysis through a prosthetic vascular graft. This single-site, prospective, single-arm study compares the investigational STARgraft with prior ePTFE controls and published data over a 6-month period, with potential additional data collection extending to 36 months post-implantation. Participants will receive a 6mm diameter STARgraft (10401) device implanted as an upper arm Brachial Artery to Axillary Vein shunt to provide vascular access for hemodialysis. The study focuses on evaluating the device's effectiveness and safety within this treatment setup, with no comparator arm in this single-arm design. During the study, participants will be monitored for primary unassisted patency and serious device-related adverse events at 6 months, along with longer-term assessments up to 36 months including assisted patency, graft infections, major events, and additional safety measures. These evaluations involve clinical follow-up visits and safety monitoring, with total participation potentially lasting up to three years after graft implantation.
CONDITIONS
Brief Title
STARgraft (10401) Pilot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients, 18 years or older
- Provided informed consent to participate
- Willing to comply with trial procedures and available for the study duration
- Able to communicate effectively with trial staff
- Diagnosed with End Stage Renal Disease
- Candidate for a new upper arm AV graft expected to need dialysis within 2 months
- Life expectancy of at least 2 years considering frailty
- Axillary vein approximately 7 mm or larger in diameter
- Brachial artery approximately 4 mm or larger in diameter
- Acceptable cardiac risk with cardiac output ≥ 3.5 l/min, pulmonary artery pressure ≤ 50 mmHg, and 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 or follow-up
- Pregnant
- History of Peritoneal Dialysis treatment within last 2 months
- Central venous catheter on the same side as implant
- Clinical morbid obesity (BMI > 40)
- Anatomical limitations discovered during vessel exposure
- Immunodeficiency syndrome
- History of hypercoagulation or bleeding disorders
- Elevated platelet count over 1 million per microliter
- History of heparin-induced thrombocytopenia syndrome
- Medically confirmed stenosis or compromised valves downstream of implant site
- Inadequate arterial flow or pressure near implant site
- Participation in another investigational trial that may interfere
- Fever over 38°C
- Known allergy to silicone or untreatable allergy to imaging contrast
- Recent or ongoing infections within 8 weeks before implantation
- Uncontrolled or poorly controlled diabetes
- Severe cardiac disease history or evidence
- Any condition judged by investigator to impact safety or study conduct
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 months or until implantation
Participants will be implanted with the STARgraft (10401) vascular graft as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.
1 implantation visit
Duration - Up to 36 months
Participants are monitored for graft effectiveness, safety, and possible complications following implantation.
Visits at 6, 12, 18, 24 and 36 months
Trial Site Locations
Total: 1 location
1
Italian Hospital
Asunción, Paraguay
Actively Recruiting
Research Team
A
Ashleigh Cooper
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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