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 Cla…