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.…