Pivotal Study of the Velocity™ pAVF System
Public ClinicalTrials.gov record NCT07153939. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multicenter Pivotal Study of the Velocity™ Percutaneous Arterio-Venous Fistula System
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07153939
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 126 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 20, 2025
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2030
- Last update posted
- Sep 1, 2026
2025 – 2030
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Trinity Research Group | Dothan | Alabama | 36301 | Recruiting |
| West Coast Kidney Institute Concord | Concord | California | 94520 | Recruiting |
| Apex Research | Riverside | California | 92505 | Recruiting |
| Vascular and Embolization Specialists | Cocoa | Florida | 32926 | Recruiting |
| Azura Vascular Care Jacksonville | Jacksonville | Florida | 32218 | Recruiting |
| Staten Island University Hospital Northwell Health | Staten Island | New York | 10305 | Recruiting |
| Surgical Specialists of Charlotte | Charlotte | North Carolina | 28207 | Recruiting |
| MUSC Health Orangeburg- Dialysis Access Institute | Orangeburg | South Carolina | 29118 | Recruiting |
| Advanced Dallas Hospital | Dallas | Texas | 75231 | Recruiting |
| Aqua Research | Houston | Texas | 77058 | Recruiting |
| Humble Vascular Surgical Center | Humble | Texas | 77338 | Recruiting |
| Fresenius Vascular Care San Antonio | San Antonio | Texas | 78207 | Recruiting |
| San Antonio Surgical Center | San Antonio | Texas | 78216 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07153939, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 1, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07153939 live on ClinicalTrials.gov.