Kidney disease

Pivotal Study of the Velocity™ pAVF System

Recruiting · 12 sites across 7 states

Always free

Study care at no cost to you

For your time and travel

Many studies pay you back

Most need no insurance or papers

Legal status usually isn't required; we'll tell you each study's requirements

Interpreters available

Ask for your language

Your choice

Voluntary — you can stop anytime

What is this study?

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

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 this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

•Adults with ESRD needing hemodialysis access, or CKD expected to need hemodialysis within 6 months.
•Specific vein and artery measurements for the procedure site: cubital perforating vein diameter 2.0 to 5.0 mm, and proximal radial artery diameter 2.0 to 4.0 mm.
•Age greater than 18 years and less than 80 years.
•Willing and able to give written informed consent.
•Willing and able to complete all study assessments and follow-up visits.

🚫 You may not be able to join if…

•If the study arm has systolic blood pressure below 100 mmHg.
•If there is blockage (occlusion) in the ulnar or radial artery at any level, or an abnormal Allen’s test (a test used to check blood flow).
•If you had a prior AV graft or prior upper arm AV fistula on the same side.
•If key measurements are outside limits, including: the distance between the cubital perforating vein and proximal radial artery is more than 3.0 mm, or the cephalic vein diameter is less than 2.5 mm from CPV to the axillary vein.
•If you are pregnant or breastfeeding.

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

✓Adults roughly 18–80
✓Have Kidney disease

!Some conditions may not be a fit: Heart / cardiovascular disease
!Not for people who are pregnant or breastfeeding

What to expect, step by step

1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

The study team can share what safety testing has been done so far.

What you need to know before you apply

What is this study testing?+

Is it safe? Who makes sure of that?+

This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Source: ClinicalTrials.gov · NCT07153939 · Locations: Alabama · California · Florida · New York · North Carolina · South Carolina · Texas