Pivotal Study of the Velocity™ pAVF System

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Chronic Kidney Disease
• Hemodialysis Access
• Arteriovenous Fistula
• End Stage Renal Disease (ESRD)

Eligibility basics and study details

Study type

Interventional

Phase

Not applicable

Ages

18 to 80 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Venova Medical

Last updated on ClinicalTrials.gov

September 2, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites