Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access

Inclusion Criteria: * CKD stage 4/5 or ESRD * Eligible for a native surgical proximal forearm radiocephalic arteriovenous fistula following assessment by the principal investigator and study sponsor * Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm * Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm * Willing and competent to give written informed consent * Willing and able to complete all study assessments and follow-up requirements Exclusion Criteria: * Distance between Proximal Radial Artery and Cubital Perforating Vein \> 3 mm * Subject study extremity systolic blood pressure \< 100mmHg Known central venous stenosis of \> 50% ipsilateral to the study extremity * Any obstruction of superficial venous outflow from intended device implant site to the axillary vein * Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test * Any previous dialysis vascular access procedures in the study extremity * History of access related hand ischemia from a previous hemodialysis vascular access of the non-study extremity which required intervention or access abandonment * Upper extremity venous occlusion and/or vessel abnormality of the study extremity that precludes endovascular AVF creation as determined by principal investigator or study sponsor * Evidence of active systemic infections on day of the procedure or infection at the procedure access site within the past 7 days * History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina * Any contraindication to antiplatelet therapy * Currently being treated with another investigational device or drug * Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated * Uncontrolled or poorly controlled diabetes defined as a HbA1C \> 10% * Known hypercoagulable condition, bleeding diathesis or coagulation disorder * Receiving anti-coagulant therapy that cannot be safely held in the peri-procedural period * Edema of the study extremity * Scheduled kidney transplant within 6 months of enrollment * Peripheral white blood cell count \< 1,500 cells/microL or \> 13,000 cells/microL and neutrophil \> 80% * Platelet count \< 75,000 cells/ microL * Serum procalcitonin level \> 0.75 ng/mL for subjects with central venous catheters * Current diagnosis of carcinoma (unless in remission \> 1 year) * Pregnant or currently breast feeding * History of substance abuse or anticipated to be non- compliant with medical care or study requirements based on investigator judgment * Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System * Any other medical condition that in the opinion of the investigator would put the welfare of the subject at risk or confound interpretation of the study data