Pivotal Study of the Velocity™ pAVF System

Inclusion Criteria

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

Exclusion Criteria

• Study extremity systolic blood pressure \< 100mmHg
• Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
• Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF.
• Distance between Cubital Perforating Vein and Proximal Radial Artery > 3.0 mm
• Cephalic vein diameter \< 2.5 mm at any point from the CPV to the axillary vein
• Central venous occlusion ipsilateral of the study extremity
• Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment.
• Evidence of active systemic infections or localized to 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
• Lymphedema of the study extremity
• Scheduled kidney transplant within 6 months of enrollment
• Peripheral white blood cell count \< 1,500 cells/μL or > 13,000 cells/μL and neutrophil > 80%
• Platelet count \< 75,000 cells/ μL
• Current diagnosis of carcinoma (unless in remission > 1 year)
• Pregnant or currently breast feeding
• 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
• Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.