STARgraft (10401) hemodialysis graft pilot

STARgraft Vascular Graft 10401 for Hemodialysis Access Pilot

This pilot will try the STARgraft (10401) hemodialysis access graft in adults with end-stage kidney disease who need a prosthetic arteriovenous graft to see if it is safe and works well.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Healionics Corporation (Industry-sponsored)
• Locations: 1 site (Asunción)
• Trial ID: NCT07555717 on ClinicalTrials.gov

What this trial studies

This single-site, prospective, single-arm pilot implants the Healionics STARgraft (10401) as an upper-arm hemodialysis access graft in adults with end-stage renal disease who require a prosthetic graft. Participants are followed for device safety and performance for 6 months with optional data collection up to 36 months post-implantation. Outcomes will be compared to historical ePTFE control data from NCT03916731 and to published benchmarks. Enrollment requires specific anatomic and cardiac criteria to confirm suitability for a prosthetic AV graft.

Who should consider this trial

Good fit: Adults with end-stage renal disease who need a new upper-arm arteriovenous graft for hemodialysis and who meet vessel size (axillary vein ≈ ≥7 mm, brachial artery ≥4 mm) and cardiac criteria are ideal candidates.

Not a fit: Patients with inadequate vessel size, downstream central venous stenosis, poor cardiac function, limited life expectancy, or those who do not require a prosthetic AV graft are unlikely to benefit from this pilot.

Why it matters

Potential benefit: If successful, the STARgraft could provide safer or longer-lasting hemodialysis access than current ePTFE grafts, potentially reducing complications and the need for reinterventions.

How similar studies have performed: Standard ePTFE grafts have established but variable patency and complication rates, and the STARgraft represents a newer graft design with limited prior clinical data beyond comparisons to historical ePTFE controls.

Eligibility criteria

Inclusion Criteria:

1. Adult patients, 18 years or older.
2. Patient has given informed consent to participate in the trial.
3. Stated willingness to comply with all trial procedures and availability for the duration of the trial.
4. Able to effectively communicate with trial personnel.
5. Indicated patient population (end stage renal disease).
6. 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.
7. Life expectancy judged to be at least 2 years with consideration of patient frailty.
8. Axillary vein approximately 7 mm in diameter or greater.
9. Brachial artery approximately 4 mm in diameter or greater.
10. Acceptable cardiac risk level (cardiac output ≥ 3.5 l/min, pulmonary artery pressure ≤ 50 mmHg, and ejection fraction ≥ 40%).
11. Systolic blood pressure equal to or greater than 120 mmHg.
12. Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram.

Exclusion Criteria:

1. Unable or unlikely to comply with trial protocol and/or follow-up.
2. Pregnancy.
3. Previous history of Peritoneal Dialysis treatment within the last 2 months
4. Central venous catheter located on same side as intended implant location.
5. Clinical morbid obesity (BMI \> 40).
6. Anatomical limitations, including issues discovered intraoperatively during vessel exposure.
7. Immunodeficiency syndrome.
8. History of hypercoagulation or bleeding disorders.
9. Elevated platelet count \> 1 million per microliter of blood.
10. History of heparin-induced thrombocytopenia syndrome
11. Medically confirmed stenosis or compromised valves in the veins downstream of the implant site.
12. Inadequate arterial flow or pressure proximal to the implant site.
13. Currently participating in another investigational drug or device trial which may clinically interfere with any endpoints of this trial.
14. Fever greater than 38°C.
15. Known allergic reaction to silicone, or untreatable allergy to imaging contrast materials.
16. Confirmed or suspected bacterial, viral or parasitic infection within 8 weeks prior to graft implant, or ongoing symptoms.
17. Uncontrolled or poorly controlled diabetes.
18. History or evidence of severe cardiac disease.
19. Any other condition which, in the judgment of the Investigator, would preclude adequate evaluation or impact patient safety or trial conduct.

Where this trial is running

Asunción

• Italian Hospital — Asunción, Paraguay (Recruiting)

Study contacts

• Study coordinator: Ashleigh Cooper

Conditions End Stage Kidney Disease; Hemodialysis; Vascular Access; Arterio-venous Grafts