Pivotal Study of the Velocity™ pAVF 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.

NCT Number	NCT07153939
Lead Sponsor	Venova Medical
Conditions	Chronic Kidney Disease, Hemodialysis Access, Arteriovenous Fistula, End Stage Renal Disease (ESRD)
Enrollment	126 participants
Start Date	2025-10-21
Primary Completion	2026-09 (estimated)
Study Completion	2030-09 (estimated)
Updated on ClinicalTrials.gov	2026-07-27