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Study identifier: NCT07153939 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Pivotal Study of the Velocity™ pAVF System

Condition: Chronic Kidney Disease · Hemodialysis Access · Arteriovenous Fistula  ·  Sponsor: Venova Medical

PhaseNA
Planned participants126
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Shant Vartanian, MD  ·  408-242-5897  ·  Venos-3@venovamed.com

Always discuss trial participation with your own doctor first.

Locations (12)

Trinity Research GroupDothan, Alabama, United StatesRecruiting
West Coast Kidney Institute ConcordConcord, California, United StatesRecruiting
Apex ResearchRiverside, California, United StatesRecruiting
Vascular and Embolization SpecialistsCocoa, Florida, United StatesRecruiting
Azura Vascular Care JacksonvilleJacksonville, Florida, United StatesRecruiting
Staten Island University Hospital Northwell HealthStaten Island, New York, United StatesRecruiting
Surgical Specialists of CharlotteCharlotte, North Carolina, United StatesRecruiting
MUSC Health Orangeburg- Dialysis Access InstituteOrangeburg, South Carolina, United StatesRecruiting
Aqua ResearchHouston, Texas, United StatesRecruiting
Humble Vascular Surgical CenterHumble, Texas, United StatesRecruiting
Fresenius Vascular Care San AntonioSan Antonio, Texas, United StatesRecruiting
San Antonio Surgical CenterSan Antonio, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07153939