Ellipsys Vascular Access System Registry

Inclusion Criteria: * Diagnosed with End-Stage Renal Disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment. * Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment Adequate quality vein base on pre-operative assessment: 1. Vein diameter of \> 2.0 mm at target anastomosis site 2. Clinically significant outflow as determined by outflow mapping (ultrasound or v venography) * Adequate quality artery base on pre-operative assessment: 1. Arterial lumen diameter of \> 2.0 mm at target anastomosis site 2. No significant calcification at the anastomosis site 3. Radial artery at the wrist suitable for catheterization * Radial artery-adjacent vein proximity \< 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure * Patent palmar arch with adequate collateral perfusion as evidenced by Negative Allen's Test * Able and willing to follow a daily aspirin and/or other anticoagulation/antiplatelet regimen, not including warfarin (Coumadin, or comparable anti-coagulant) Exclusion Criteria: * Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%) * History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment * Evidence of clinically significant vascular disease at the radial artery/adjacent vein site on the ipsilateral side * Systolic pressures \< 100 mg Hg at the time of treatment * Suspected or confirmed skin disease at the skin entry site * Immunocompromised patients (e.g. HIV positive) * Edema of the upper extremity on the ipsilateral side * Patients requiring immunosuppressant therapy such as Sirolimus (Rapamune®) or - Prednisone at a dose of \> 10 mg per day * Peripheral white blood cell count \<1.5 K/mm3 or platelet count \<75,000 cells/mm3 * Known bleeding diathesis or coagulation disorder * Receiving warfarin (Coumadin, or comparable anti-coagulant) therapy * Patients with acute or active infection