Early Feasibility of the Velocity™ Percutaneous pAVF System

Study Overview
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Brief Summary
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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.

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

Conditions
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Arteriovenous Fistula

Intervention / Treatment
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* Device: Velocity pAVF system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Arm<br> | Device: Velocity pAVF system<br>* A second generation percutaneous AVF device that creates an AVF between the proximal radial artery and cubital perforating vein.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Defined as Velocity deployment and delivery system withdrawal with intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein 2 cm central from the pAVF anastomosis | Immediate | 
| Serious Adverse Device Events | Defined as any Serious Adverse Event that reasonably suggests is caused by the device or procedure. | 6 weeks | 
| Major Reintervention | Defined as any open surgery, thrombectomy or thrombolysis in the index limb following pAVF creation. | 6 weeks |