Evaluation of STARgraft-2 for Hemodialysis Access

Inclusion Criteria: 1. Male or female, \> 18 years or age. 2. Patient has given informed consent to participate in the trial. 3. Stated willingness to comply with all study procedures and availability for the duration of the study. 4. Able to effectively communicate with study personnel. 5. Candidate for a new arterio-venous graft placed in the upper arm. 6. Life expectancy judged to be at least 2 years. 7. Axillary vein of greater than or equal to 7 mm in diameter. 8. Brachial artery of greater than or equal to 4 mm in diameter. 9. Acceptable cardiac risk level (Cardiac Output ≥ 3.5 L/min, Pulmonary Artery Pressure ≤ 50 mmHg, Ejection Fraction ≥ 40%) 10. Systolic blood pressure equal to or greater than 120 mmHg. 11. 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. Clinically morbid obesity. 4. Anatomical limitations. 5. Immunodeficiency syndrome. 6. History of bacterial infection within 8 weeks prior to graft implantation. 7. History of hypercoagulation or bleeding disorders. 8. Elevated platelet count \> 1 million per microliter of blood. 9. History of heparin-induced thrombocytopenia syndrome (HIT). 10. Medically confirmed stenosis of the veins downstream of the implant site. 11. Inadequate arterial flow or pressure proximal to the implant site. 12. Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial. 13. Fever greater than 38° C. 14. Prior allergic reaction to silicone. 15. Confirmed or suspected COVID-19 infection within 8 weeks prior to graft implant, or ongoing COVID-19 symptoms