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Pivotal Study of the Velocity™ pAVF System
NCT07153939 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Velocity Percutaneous Arteriovenous Fistula
Study Locations (10)
Texas
- Aqua Research — Houston
- Humble Vascular Surgical Center — Humble
- Fresenius Vascular Care San Antonio — San Antonio
- San Antonio Surgical Center — San Antonio
California
- West Coast Kidney Institute Concord — Concord
- Apex Research — Riverside
Florida
- Vascular and Embolization Specialists — Cocoa
- Azura Vascular Care Jacksonville — Jacksonville
Alabama
- Trinity Research Group — Dothan
North Carolina
- Surgical Specialists of Charlotte — Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2025-10-21 |
| Est. Completion | 2030-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07153939
The ClinicalTrials.gov registry entry for NCT07153939 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Venova Medical, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 1 intervention — of which Velocity Percutaneous Arteriovenous Fistula is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07153939 reports 10 study locations spanning 5 distinct geographic areas — top geographies include Texas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07153939 about?
NCT07153939 is a clinical study titled "Pivotal Study of the Velocity™ pAVF System". 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 wit...
What is the current status of trial NCT07153939?
This trial is currently recruiting. It is a NA study. The enrollment target is 126 participants. The study started on 2025-10-21. Estimated completion is 2030-09.
What conditions does trial NCT07153939 study?
This clinical trial studies the following conditions: Chronic Kidney Disease, End Stage Renal Disease (ESRD), Arteriovenous Fistula, Hemodialysis Access. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07153939?
The interventions under investigation include: Velocity Percutaneous Arteriovenous Fistula (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07153939?
This trial is sponsored by Venova Medical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07153939 being conducted?
This trial has 10 study locations across Alabama, California, Florida, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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