NCT07153939 · Venova Medical
Pivotal Study of the Velocity™ pAVF System
(VENOS-3)
What this study is about
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).
View original scientific 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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- Any contraindication to antiplatelet therapy
- Currently being treated with another investigational device or drug
- Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
- Uncontrolled or poorly controlled diabetes defined as a HbA1C \> 10%
- Known hypercoagulable condition, bleeding diathesis or coagulation disorder
- Lymphedema of the study extremity
- Scheduled kidney transplant within 6 months of enrollment
- Peripheral white blood cell count \< 1,500 cells/μL or \> 13,000 cells/μL and neutrophil \> 80%
- Platelet count \< 75,000 cells/ μL
- Current diagnosis of carcinoma (unless in remission \> 1 year)
- Pregnant or currently breast feeding
- Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System
- Any other medical condition that in the opinion of the investigator would put the welfare of the subject at risk or confound interpretation of the study data
- Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.
Where
- Dothan, Alabama
- Concord, California
- Riverside, California
- Cocoa, Florida
- Jacksonville, Florida
- Staten Island, New York
- Charlotte, North Carolina
- Orangeburg, South Carolina
- Houston, Texas
- Humble, Texas
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations