Early Feasibility of the Velocity™ Percutaneous PAVF System

Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System

An early feasibility study of the the initial safety and efficacy of the Velocity Percutaneous Arterio-Venous Fistula (pAVF) System when used to percutaneously create an arteriovenous fistula in patients with ESRD requiring hemodialysis vascular access.

Inclusion Criteria:

• Age 18 years or older
• Diagnosed with ESRD and currently on hemodialysis for less than 12 months using a central venous catheter for access
• Eligible for a native surgical brachiocephalic arteriovenous fistula following assessment by the principal investigator and study sponsor
• Cubital perforating vein diameter of > 2.5 mm and length > 10.0 mm
• Proximal radial artery diameter ≥ 2.0 mm
• Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure
• Willing and competent to give written informed consent

Exclusion Criteria:

• Distance between Proximal Radial Artery and Cubital Perforating vein > 3mm
• Ipsilateral arm systolic blood pressure < 110 mmHg
• Known central venous stenosis or central vein narrowing > 50% ipsilateral to the study extremity
• Any obstruction of venous outflow from device implant site to the axillary vein
• Patients 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 steal syndrome (hand ischemia) from a previous hemodialysis vascular access of the non-study extremity which required intervention or access abandonment
• Upper extremity venous occlusion(s) and/or vessel abnormality(ies) 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 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
• 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%
• Hypercoagulable condition, bleeding diathesis or coagulation disorder
• Receiving anti-coagulant therapy that cannot be safely held in the peri-procedural period
• Edema of the upper arm of the study extremity
• Scheduled kidney transplant within 6 months of enrollment
• Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3
• Current diagnosis of carcinoma (defined as 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 NiTi alloy or any of the components of the Velocity Implant or Delivery System
• Written informed consent not obtainable