Early Feasibility of the Velocity™ Percutaneous pAVF 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 olderDiagnosed with ESRD and currently on hemodialysis for less than 12 months using a central venous catheter for accessEligible for a native surgical brachiocephalic arteriovenous fistula following assessment by the principal investigator and study sponsorCubital perforating vein diameter of > 2.5 mm and length > 10.0 mmProximal radial artery diameter ≥ 2.0 mmPatient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedureWilling and competent to give written informed consentExclusion Criteria:Distance between Proximal Radial Artery and Cubital Perforating vein > 3mmIpsilateral arm systolic blood pressure < 110 mmHgKnown central venous stenosis or central vein narrowing > 50% ipsilateral to the study extremityAny obstruction of venous outflow from device implant site to the axillary veinPatients with occlusion of the ulnar or radial artery at any level or an abnormal Allen's testAny previous dialysis vascular access procedures in the study extremityHistory of steal syndrome (hand ischemia) from a previous hemodialysis vascular access of the non-study extremity which required intervention or access abandonmentUpper 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 sponsorEvidence of active systemic infections on day of the procedure or infection at the access site within the past 7 daysHistory 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 anginaCurrently being treated with another investigational device or drugKnown adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicatedUncontrolled or poorly controlled diabetes defined as a HbA1C > 10%Hypercoagulable condition, bleeding diathesis or coagulation disorderReceiving anti-coagulant therapy that cannot be safely held in the peri-procedural periodEdema of the upper arm of the study extremityScheduled kidney transplant within 6 months of enrollmentPeripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3Current diagnosis of carcinoma (defined as in remission < 1 year)Pregnant or currently breast feedingHistory of substance abuse or anticipated to be non- compliant with medical care or study requirements based on investigator judgmentAllergies to NiTi alloy or any of the components of the Velocity Implant or Delivery SystemWritten informed consent not obtainable