RecruitingNot ApplicableNCT07153939

Pivotal Study of the Velocity™ pAVF System

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

Sponsor

Venova Medical

Enrollment

126 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

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

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. 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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a medical device called the Velocity system for creating a new type of blood vessel access (called a percutaneous arteriovenous fistula or pAVF) in the arm for kidney dialysis patients. This procedure connects an artery and vein without open surgery. **You may be eligible if...** - You are between 18 and 80 years old - You have end-stage kidney disease and need dialysis access, or your kidneys are failing and you expect to need dialysis within 6 months - Your arm blood vessels meet specific size requirements for the procedure - You are willing to attend all follow-up visits **You may NOT be eligible if...** - Your arm blood pressure is very low or arteries are blocked or abnormal - You have had a previous graft or upper arm fistula on the same arm - You have severe heart disease, recent heart attack, or uncontrolled diabetes (HbA1c above 10%) - You are pregnant or breastfeeding - You have certain blood disorders or a scheduled kidney transplant within 6 months - You are allergic to nickel or titanium Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVelocity Percutaneous Arteriovenous Fistula

The Velocity pAVF is a catheter-based device used to create an arteriovenous fistula for hemodialysis access through a minimally invasive, percutaneous procedure. Unlike surgical AVF creation or other pAVF systems, Velocity is designed to simplify the procedure and improve consistency of maturation and long-term function. All participants in this study will undergo AVF creation using the Velocity pAVF.