Pivotal Study of the Velocity™ pAVF System (NCT07153939) | Clinical Trial Compass
RecruitingNot Applicable
Pivotal Study of the Velocity™ pAVF System
United States126 participantsStarted 2025-10-21
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ESRD requiring hemodialysis access or CKD with anticipated need for hemodialysis within 6 months
. Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm
. Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm
. Age \> 18 years and \< 80 years
. Willing and competent to give written informed consent
. Willing and able to complete all study assessments and follow-up requirements
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is testing the Velocity™ pAVF system to create an arteriovenous fistula using a device rather than traditional surgery, can you explain how this approach differs from the standard surgical AVF procedure I might otherwise receive for hemodialysis access?
2The trial is measuring whether the fistula reaches 'physiologic maturation,' meaning it becomes usable for dialysis — what are the realistic chances that the fistula might not mature, and what would happen to my dialysis access plan if that occurs?
3One of the primary things being tracked in this study is 'serious adverse device effects' — what kinds of complications or device-related risks have been seen with similar percutaneous fistula technologies, and how should I weigh those against the risks of conventional surgical fistula creation?
4This trial does not have a traditional phase designation, which suggests it may be a pivotal study aimed at regulatory approval rather than an early safety test — does that mean there is already some prior safety data on this device, and can you help me understand what is and isn't yet known?
5Given that I would need a functioning hemodialysis access either way, would it be worth discussing whether getting a standard surgical AVF or graft now might be a more reliable path for my immediate dialysis needs compared to enrolling in this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Study extremity systolic blood pressure \< 100mmHg
. Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
. Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF.
. Distance between Cubital Perforating Vein and Proximal Radial Artery \> 3.0 mm
. Cephalic vein diameter \< 2.5 mm at any point from the CPV to the axillary vein
. Central venous occlusion ipsilateral of the study extremity
. Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment.
. Evidence of active systemic infections or localized to the procedure access site within the past 7 days