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NCT07153939 · ClinicalTrials.gov registry record · NA
Pivotal Study of the Velocity™ pAVF System
A NA study of Chronic Kidney Disease and End Stage Renal Disease (ESRD), sponsored by Venova Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 126
- Enrollment target
- 10
- Study locations
NCT07153939: Recruiting NA study of Chronic Kidney Disease and End Stage Renal Disease (ESRD), sponsored by Venova Medical.
NCT07153939 is a NA study of Chronic Kidney Disease and End Stage Renal Disease (ESRD) that is actively recruiting participants, run by Venova Medical. The registered enrollment target is 126 participants, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (96% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07153939, a NA study of Chronic Kidney Disease and End Stage Renal Disease (ESRD), is actively recruiting participants, sponsored by Venova Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
The proportion of participants that reach the binary outcome of Physiologic Maturation. Physiologic Maturation is a composite measure, reached when Duplex ultrasound demonstrates a brachial artery blood flow of ≥ 500 ml/min and an outflow vein diameter of ≥ 5 mm.
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 |
What NCT07153939 shows while recruiting
NCT07153939 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (96% lower).
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.
NCT07153939 lists 10 locations in 5 states (Texas, California, Florida).
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.
What interventions are being tested in trial NCT07153939?
The interventions under investigation include: Velocity Percutaneous Arteriovenous Fistula (DEVICE).
Who is sponsoring clinical trial NCT07153939?
This trial is sponsored by Venova Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07153939's enrollment target sits among peer trials
126 49th of 101 higher than 53 of 101 other Chronic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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