Pivotal Study of the Velocity™ pAVF System

Multicenter Pivotal Study of the Velocity™ Percutaneous Arterio-Venous Fistula System

This study will evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method for creating dialysis access. People with kidney failure often require dialysis, which depends on having a reliable arteriovenous fistula (AVF). Traditionally, AVFs are created with surgery, but surgery can involve incisions, longer recovery, and sometimes additional procedures before the AVF can be used.

The Velocity System is designed to create an AVF through a small puncture in the skin using a catheter-based approach, without open surgery. This pivotal study will assess how safe the procedure is and how well it works for patients who need dialysis.

The study will take place at multiple centers in the United States and will enroll adults with kidney failure who are candidates for fistula creation. Participants will undergo the Velocity procedure and then be followed closely with exams, ultrasounds, and dialysis assessments for up to five years.

Taking part is voluntary. Patients may benefit from a less invasive approach to dialysis access, but the main goal is to collect information that could improve future care for people with kidney failure.

Inclusion Criteria:

1. ESRD requiring hemodialysis access or CKD with anticipated need for hemodialysis within 6 months
2. Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm
3. Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm
4. Age > 18 years and < 80 years
5. Willing and competent to give written informed consent
6. Willing and able to complete all study assessments and follow-up requirements

Exclusion Criteria:

1. Study extremity systolic blood pressure < 100mmHg
2. Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
3. Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF.
4. Distance between Cubital Perforating Vein and Proximal Radial Artery > 3.0 mm
5. Cephalic vein diameter < 2.5 mm at any point from the CPV to the axillary vein
6. Central venous occlusion ipsilateral of the study extremity
7. Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment.
8. Evidence of active systemic infections or localized to the procedure access site within the past 7 days
9. 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
10. Any contraindication to antiplatelet therapy
11. Currently being treated with another investigational device or drug
12. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
13. Uncontrolled or poorly controlled diabetes defined as a HbA1C > 10%
14. Known hypercoagulable condition, bleeding diathesis or coagulation disorder
15. Lymphedema of the study extremity
16. Scheduled kidney transplant within 6 months of enrollment
17. Peripheral white blood cell count < 1,500 cells/μL or > 13,000 cells/μL and neutrophil > 80%
18. Platelet count < 75,000 cells/ μL
19. Current diagnosis of carcinoma (unless in remission > 1 year)
20. Pregnant or currently breast feeding
21. Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System
22. 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
23. Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.