Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis

Exclusion Criteria

• •1. Subjects who are optimal candidates for radiocephalic AVF as indicated by meeting ALL of the following criteria:
• •1. No previous failed AVF.
• •2. Cephalic vein diameter on ultrasound of more than 3.5mm.
• •3. Radial artery diameter on ultrasound of more than 3mm.
• •4. Vein depth of less than 0.5cm from the skin.
• •5. Normal Allen's test indicating that ulnar artery flow to the hand is sufficient.
• •6. No calcification in the wall of the distal radial artery.
• •7. Sufficient length of the proposed fistula outflow vein to provide an adequate (at least 6 cm) cannulation segment.
• •8. No evidence of iatrogenic injury to target artery or vein.
• •2. Uncontrolled diabetes;
• •a. HbA1c \>10% (at Screening).
• •3. History or evidence of severe peripheral arterial disease in the extremity selected for implant.
• •4. Known or suspected central vein stenosis or obstruction on the side of planned SA creation, unless corrected prior to randomization.
• •5. Planned AVF creation that requires more than one stage to complete. (e.g. basilic vein transposition AVF performed in 2 stages).
• •6. Planned AVF creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices).
• •7. Treatment with any investigational drug or device within 60 days prior to study entry (Day 0) or ongoing participation in a clinical trial of an investigational product.
• •8. Cancer that is actively being treated with a cytotoxic agent.
• •9. Documented hyper-coagulable state.
• •10. Bleeding diathesis.
• •11. Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
• •1. Low dose glucocorticoid therapy (e.g. 5-10mg prednisone \[Deltason\]) is acceptable.
• •2. High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
• •3. Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded.
• •4. The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial:
• •* tacrolimus or FK506 \[Prograf\]
• •* mycophenolate mofetil \[Cellcept\],
• •* cyclosporine \[Sandimmune or Gengraf\]
• •* sirolimus \[Rapamune\] (this only includes systemically administered, drug eluting stents are acceptable)
• •12. Anticipated renal transplant within 6 months.
• •13. History of heparin-induced thrombocytopenia.
• •14. Venous outflow from SA cannot be located more centrally than the venous outflow of any previous failed access in that extremity.
• •15. Active local or systemic infection (white blood cells \[WBC\] \> 15,000 cells/mm3 at Screening). If the infection resolves, the subject must be at least one week post resolution of that infection before SA creation.
• •16. Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy.
• •17. Pregnant women, or women intending to become pregnant during the course of the trial.
• •18. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA.
• •19. Previous enrollment in this study or any other study with HAV.
• •20. Employees of Humacyte and employees or relatives of an investigator.