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

Inclusion Criteria

• Subjects with ESRD who need placement of an AV graft in the arm.
• Either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation.
• Suitable anatomy for implantation of straight or looped conduits in either the forearm or upper arm (not crossing the elbow).
• Hemoglobin ≥8 g/dL and platelet count ≥100,000 cells/mm3 prior to Day 0 (within 35 days).
• Other hematological and biochemical parameters within a range consistent with ESRD prior to Day 0 (within 35 days).
• Adequate liver function prior to Day 0 (within 35 days).
• Female subjects must be either:
• Of non-childbearing potential Or
• Must agree to use at least one form of birth control methods for the duration of the study.
• Subject, or legal representative, able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits.
• Life expectancy of at least 1 year.

Exclusion Criteria

• History or evidence of severe peripheral vascular disease in the intended arm for implantation.
• Known or suspected central vein stenosis or conduit occlusion on the ipsilateral side of planned implantation, unless the stenosis is corrected prior to study conduit implantation.
• Treatment with any investigational drug or device within 60 days prior to study entry (Day 0).
• Cancer that is actively being treated with a cytotoxic agent.
• Documented hyper-coagulable state.
• Bleeding diathesis.
• Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
• High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
• Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded.
• 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] i-Sirolimus administered systemically (Sirolimus in drug eluting stents is NOT an exclusion)
• Anticipated renal transplant within 6 months.
• Venous outflow from study conduit cannot be placed more centrally than the venous outflow of any previous failed access in that extremity.
• 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 implantation.
• Known serious allergy to planned antiplatelet agent.
• Pregnant women, or women intending to become pregnant during the course of the trial.
• Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the study conduit.
• Previous enrollment in this study or any other study with the HAV.
• Employees of Humacyte and employees or relatives of the investigator.