Velocity pAVF system for creating dialysis fistulas through a small skin puncture

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

This trial will test whether the minimally invasive Velocity pAVF system can create a dependable dialysis fistula in adults with kidney failure or those expected to need hemodialysis soon.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Venova Medical (Industry-sponsored)
• Locations: 10 sites (Dothan, Alabama and 9 other locations)
• Trial ID: NCT07153939 on ClinicalTrials.gov

What this trial studies

The study enrolls adults with end-stage renal disease or chronic kidney disease who are candidates for a new arteriovenous fistula and have suitable vessel anatomy, and uses the Velocity percutaneous AVF system to create an arteriovenous connection via a catheter-based puncture rather than open surgery. Procedures are performed at multiple U.S. centers and patients are followed with physical exams, duplex ultrasound, and dialysis assessments to monitor fistula function and safety. Follow-up continues for up to five years to track maturation, usability for dialysis, and any complications. Key eligibility focuses on vessel diameters and spacing, while exclusions include occluded arteries, prior ipsilateral grafts or fistulas, central venous occlusion, severe arterial calcification, and low blood pressure.

Who should consider this trial

Good fit: Adults 18–79 with ESRD or CKD likely to need hemodialysis who have a cubital perforating vein 2.0–5.0 mm, a proximal radial artery 2.0–4.0 mm, and vessel separation ≤3.0 mm are the ideal candidates.

Not a fit: Patients with occluded ulnar or radial arteries, an abnormal Allen's test, prior ipsilateral AV graft or fistula, central venous occlusion, severe radial artery calcification, very small cephalic veins, or systolic blood pressure below 100 mmHg are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the device could offer a less invasive way to create a usable dialysis fistula with smaller wounds and faster recovery than traditional surgery.

How similar studies have performed: Other percutaneous/endovascular AVF systems (endoAVF) have shown promising short- to mid-term results in earlier studies, but long-term comparative evidence is still limited.

Eligibility criteria

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.

Where this trial is running

Dothan, Alabama and 9 other locations

• Trinity Research Group — Dothan, Alabama, United States (Recruiting)
• West Coast Kidney Institute Concord — Concord, California, United States (Recruiting)
• Apex Research — Riverside, California, United States (Recruiting)
• Vascular and Embolization Specialists — Cocoa, Florida, United States (Recruiting)
• Azura Vascular Care Jacksonville — Jacksonville, Florida, United States (Recruiting)
• Surgical Specialists of Charlotte — Charlotte, North Carolina, United States (Recruiting)
• Aqua Research — Houston, Texas, United States (Recruiting)
• Humble Vascular Surgical Center — Humble, Texas, United States (Recruiting)
• Fresenius Vascular Care San Antonio — San Antonio, Texas, United States (Recruiting)
• San Antonio Surgical Center — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Shant Vartanian, MD

Conditions Chronic Kidney Disease; Hemodialysis Access; Arteriovenous Fistula; End Stage Renal Disease; percutaneous AVF; pAVF; endovascular AVF; endoAVF