Evaluation of STARgraft-2 for Hemodialysis Access

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