Pivotal Study of the Velocity™ pAVF System (NCT07153939)
Multicenter Pivotal Study of the Velocity™ Percutaneous Arterio-Venous Fistula System
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Trinity Research Group — Dothan, Alabama
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- Trinity Research Group — Dothan, Alabama
- West Coast Kidney Institute Concord — Concord, California
- Apex Research — Riverside, California
- Vascular and Embolization Specialists — Cocoa, Florida
- Azura Vascular Care Jacksonville — Jacksonville, Florida
- Staten Island University Hospital Northwell Health — Staten Island, New York
- Surgical Specialists of Charlotte — Charlotte, North Carolina
- MUSC Health Orangeburg- Dialysis Access Institute — Orangeburg, South Carolina
- Aqua Research — Houston, Texas
- Humble Vascular Surgical Center — Humble, Texas
- Fresenius Vascular Care San Antonio — San Antonio, Texas
- San Antonio Surgical Center — San Antonio, Texas
📞 Contact the Study Coordinator
Phone: (408) 242-5897
Email: Venos-3@venovamed.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.