Arteriovenous Fistula
Conditions
Brief summary
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.
Interventions
DEVICEVelocity pAVF system
A second generation percutaneous AVF device that creates an AVF between the proximal radial artery and cubital perforating vein.
Sponsors
Venova Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | Immediate | 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 |
| Serious Adverse Device Events | 6 weeks | Defined as any Serious Adverse Event that reasonably suggests is caused by the device or procedure. |
| Major Reintervention | 6 weeks | Defined as any open surgery, thrombectomy or thrombolysis in the index limb following pAVF creation. |
Countries
Paraguay
Outcome results
None listed