early feasibility study of the velocity™ percutaneous arterio-venous fistula system for creating hemodialysis vascular access

Conditions: Chronic Kidney Disease Requiring Hemodialysis; End Stage Renal Disease (ESRD)

Summary: 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.


Eligibility criteria:
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 \ 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 \ 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

Keywords: dialysis access hemodialysis av fistula percutaneous avf