Pivotal Study of the Velocity™ pAVF System

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Velocity Percutaneous Arteriovenous Fistula — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Oct 21, 2025

Status verified

Jan 2026

Primary completion

Sep 30, 2026

Completion

Sep 30, 2030

Study Design

Enrollment

126 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Velocity pAVF System Treatment Arm
  Participants in this single-arm, open-label study will undergo creation of a dialysis access using the Velocity Percutaneous Arteriovenous Fistula (pAVF). The Velocity pAVF is designed to create an arteriovenous fistula (AVF) using a minimally invasive, catheter-based procedure through the skin, rather than open surgery. All subjects enrolled will receive the Velocity pAVF procedure. After the procedure, participants will be followed with physical examinations, duplex ultrasound, and dialysis assessments to evaluate fistula maturation, usability for hemodialysis, and long-term function. Additional procedures, if needed to assist maturation or maintain access function, will be recorded. Safety will be monitored throughout the study, including assessment of device-related and procedure-related complications.

Primary Outcome Measure

Physiologic Maturation [ Time Frame: 6 weeks ]

Central Contacts

• Shant Vartanian, MD
  408-242-5897
  [email protected]

Locations (10)

Find similar trials in Dothan, AL

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