Pivotal Study of the Velocity™ pAVF System

Inclusion Criteria:

1. ESRD requiring hemodialysis access or CKD with anticipated need for hemodialysis within 6 months
2. Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm
3. Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm
4. Age \> 18 years and \< 80 years
5. Willing and competent to give written informed consent
6. Willing and able to complete all study assessments and follow-up requirements

Exclusion Criteria:

1. Study extremity systolic blood pressure \< 100mmHg
2. Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
3. Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF.
4. Distance between Cubital Perforating Vein and Proximal Radial Artery \> 3.0 mm
5. Cephalic vein diameter \< 2.5 mm at any point from the CPV to the axillary vein
6. Central venous occlusion ipsilateral of the study extremity
7. Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment.
8. Evidence of active systemic infections or localized to the procedure access site within the past 7 days
9. 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
10. Any contraindication to antiplatelet therapy
11. Currently being treated with another investigational device or drug
12. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
13. Uncontrolled or poorly controlled diabetes defined as a HbA1C \> 10%
14. Known hypercoagulable condition, bleeding diathesis or coagulation disorder
15. Lymphedema of the study extremity
16. Scheduled kidney transplant within 6 months of enrollment
17. Peripheral white blood cell count \< 1,500 cells/μL or \> 13,000 cells/μL and neutrophil \> 80%
18. Platelet count \< 75,000 cells/ μL
19. Current diagnosis of carcinoma (unless in remission \> 1 year)
20. Pregnant or currently breast feeding
21. Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System
22. 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
23. Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.