Evaluation of the Velocity Percutaneous Arteriovenous Fistula System for Dialysis Access in Adults with Kidney Failure

What this Trial Is About

Researchers are evaluating the Velocity Percutaneous Arteriovenous Fistula pAVF System, a new minimally invasive device designed to create dialysis access for adults with kidney failure. This study aims to assess the safety and effectiveness of this catheter-based approach compared to traditional surgical methods. The study includes adults aged 18 to 80 years who require hemodialysis access or are expected to need it within six months. Participants will undergo the Velocity pAVF procedure, which creates an arteriovenous fistula through a small skin puncture without open surgery. After the procedure, they will be monitored with physical exams, duplex ultrasounds, and dialysis assessments to evaluate fistula maturation, usability, and long-term function. Any additional procedures needed to assist maturation or maintain access will be recorded. Safety monitoring will include tracking device- and procedure-related complications. During the study, participants will have follow-up visits for up to five years, during which their fistulas functional and physiological maturation will be assessed at specific intervals, including 6 weeks, 3 months, 6 months, and yearly thereafter. Researchers will measure outcomes such as time to first hemodialysis, catheter use duration, patency rates, and adverse events. This long-term follow-up will help gather information to improve dialysis access care.

Pivotal Study of the Velocity™ pAVF System