Clinical Research Directory

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.