Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access

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

The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.

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 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
• Receiving anti-coagulant therapy that cannot be safely held in the peri-procedural period
• Edema of the study extremity
• Scheduled kidney transplant within 6 months of enrollment
• Peripheral white blood cell count < 1,500 cells/microL or > 13,000 cells/microL and neutrophil > 80%
• Platelet count < 75,000 cells/ microL
• Serum procalcitonin level > 0.75 ng/mL for subjects with central venous catheters
• Current diagnosis of carcinoma (unless 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 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