Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure

Inclusion Criteria: * Patients with ESRD who are not, or who are no longer, candidates for creation of an autologous AV fistula and therefore need placement of an AV graft to start or maintain hemodialysis therapy; * Age 18 to 80 years old, inclusive; * Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow); * For patients NOT on Coumadin / warfarin, international normalized ratio (INR) ≤1.5; * Able and willing to give informed consent; * Anticipated life expectancy of at least 1 year. Additional inclusion criteria on Day 0 (intraoperative): * Both vessels have been exposed and are deemed appropriate for implantation implantation (i.e. based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow and is safely clampable (i.e. artery has lack of significant calcification); and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction). Exclusion Criteria: * History or evidence of severe cardiac disease (New York Heart Association \[NYHA\] Functional Class III or IV), myocardial infarction within 6 months prior to enrollment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina; * Diabetes with a hemoglobin A1c (HbA1c) \> 10% * For upper arm straight configuration, antecubital fossa crease to axillary crease distance \< 18 cm. * History or evidence of severe peripheral arte…