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Chronic Kidney DiseaseVENOS-3NCT07153939

Pivotal Study of the Velocity™ pAVF System

A study testing Velocity Percutaneous Arteriovenous Fistula in people with Chronic Kidney Disease and Hemodialysis Access, run by Venova Medical at 13 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Velocity Percutaneous Arteriovenous Fistula
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
13 sitesUnited States
Study dates
21 Oct 2025to Sep 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shant Vartanian, MD contact

408-242-5897

Venos-3@venovamed.com

13 sites in 1 country

United States13 sites, 13 recruiting

  • Surgical Specialists of Charlotte

    Charlotte, North Carolina, 28207

    Jason Burgess, MD, 704-333-0741, jburgess@ssclt.com

    Jason Burgess, MD

    Recruiting

  • Vascular and Embolization Specialists

    Cocoa, Florida, 32926

    Laura Dalton, 321-321-3001, forms@vascularembo.com

    Derek Mittleider, MD

    Recruiting

  • West Coast Kidney Institute Concord

    Concord, California, 94520

    Michael Murphy, MD, 925-686-1230, michael.murphy@westcoastkidney.com

    Michael Murphy, MD

    Recruiting

  • Advanced Dallas Hospital

    Dallas, Texas, 75231

    Neghae Mawla, MD, 945-234-7600, mawlamd@gmail.com

    Neghae Mawla, MD

    Recruiting

  • Trinity Research Group

    Dothan, Alabama, 36301

    334-456-5511, research.trinityresearchgroup@gmail.com

    Jason Beaver, MD

    Recruiting

  • Aqua Research

    Houston, Texas, 77058

    Rhea Sharma, 346-800-1300, rheas@aqua-ri.com

    Rupal Patel, MD

    Recruiting

  • Humble Vascular Surgical Center

    Humble, Texas, 77338

    Ruchdi Barakat, MD, 346-616-5862, ruchdi.barakat@surgerypartners.com

    Brett Stephens, MD

    Recruiting

  • Azura Vascular Care Jacksonville

    Jacksonville, Florida, 32218

    Christine Mulligan, 717-818-0153, Christine.Mulligan@azuracare.com

    Mark Gorrie, DO

    Recruiting

  • MUSC Health Orangeburg- Dialysis Access Institute

    Orangeburg, South Carolina, 29118

    Virginia Anderson, 803-395-3878, andersvi@musc.edu

    John Aruny, MD

    Recruiting

  • Apex Research

    Riverside, California, 92505

    951-687-6300, dzdawoud@namg.net

    Dalia Dawoud, MD

    Recruiting

  • Fresenius Vascular Care San Antonio

    San Antonio, Texas, 78207

    Christine Mulligan, 717-818-0153, Christine.Mulligan@azuracare.com

    Rashid Sharaf, MD

    Recruiting

  • San Antonio Surgical Center

    San Antonio, Texas, 78216

    Rajeev Narayan, MD, 210-342-2233, rnarayan@sakidney.com

    Rajeev Narayan, MD

    Recruiting

  • Staten Island University Hospital Northwell Health

    Staten Island, New York, 10305

    Cindy Lin, 718-226-6422, clin14@northwell.edu

    Vincent Gallo, MD

    Recruiting

Other trials in United States

About this study

Official title: Multicenter Pivotal Study of the Velocity™ Percutaneous Arterio-Venous Fistula 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 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.

Read more

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.

Being tested
Velocity Percutaneous Arteriovenous Fistula
Keywords
percutaneous AVF, pAVF, endovascular AVF, endoAVF, Arteriovenous Fistula, AVF, VENOS-3, VENOS3
Medical subject headings
Renal Insufficiency, Chronic, Arteriovenous Fistula, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Velocity Percutaneous Arteriovenous FistulaDevice

    Also called Velocity pAVF

    The Velocity pAVF is a catheter-based device used to create an arteriovenous fistula for hemodialysis access through a minimally invasive, percutaneous procedure. Unlike surgical AVF creation or other pAVF systems, Velocity is designed to simplify the procedure and improve consistency of maturation and long-term function. All participants in this study will undergo AVF creation using the Velocity pAVF.

Study groups in NCT07153939
Study groupRoleWhat they receive
Velocity pAVF System Treatment ArmExperimentalParticipants in this single-arm, open-label study will undergo creation of a dialysis access using the Velocity Percutaneous Arteriovenous Fistula (pAVF). The Velocity pAVF is designed to create an arteriovenous fistula (AVF) using a minimally invasive, catheter-based procedure through the skin, rather than open surgery. All subjects enrolled will receive the Velocity pAVF procedure. After the procedure, participants will be followed with physical examinations, duplex ultrasound, and dialysis assessments to evaluate fistula maturation, usability for hemodialysis, and long-term function. Additional procedures, if needed to assist maturation or maintain access function, will be recorded. Safety will be monitored throughout the study, including assessment of device-related and procedure-related complications.
Receives: Device: Velocity Percutaneous Arteriovenous Fistula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physiologic Maturation

    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.

    Measured: 6 weeks

  2. Serious Adverse Device Effect

    Any Serious Adverse Event that reasonably suggests is caused by the device or procedure

    Measured: 30 days

Secondary outcomes (13)

  1. Functional Maturation

    The number of participants with successful two needle cannulation for 75% of dialysis sessions over a consecutive 4 weeks period following pAVF creation

    Measured: 6 months

  2. Unassisted Functional Maturation

    The number of participants that reach functional maturation without any endovascular or surgical interventions to facilitate maturation and/or manage complications

    Measured: 6 months

  3. Physiologic Maturation

    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.

    Measured: 3 months

  4. Time to First Hemodialysis

    The interval from the time of pAVF creation to the first hemodialysis session using 2-needles in the ESRD subgroup

    Measured: Through 12 month follow up, on average at 3 months

  5. Number of Catheter Days

    The number of days from pAVF creation to central venous catheter removal in the ESRD subgroup.

    Measured: Through 12 month follow up, on average at 3 months

  6. Access Circuit Primary Patency

    The interval of time from access creation until the first occurrence of any reintervention to maintain or reestablish patency or until access thrombosis or abandonment.

    Measured: Assessed up to 5 years

  7. Velocity pAVF Primary Patency

    The interval of time from access creation until the first occurrence of reintervention or thrombosis directly attributable to a causative lesion within 5 mm of each end of the Velocity pAVF.

    Measured: Assessed up to 5 years

  8. Access Circuit Cumulative Patency

    The interval of time from access creation until the final abandonment of the access, inclusive of all successful interventions to maintain or restore patency

    Measured: Assessed up to 5 years

  9. Technical Success

    The proportion of subjects with successful delivery of the implant between the perforating cubital vein and the radial artery, and removal of the delivery system, at the index procedure.

    Measured: Immediately after the intervention

  10. Procedural Success

    The proportion of subjects with intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein

    Measured: Immediately after the intervention

  11. Freedom from Reintervention

    The duration from the time of access creation until the first occurrence of a reintervention required to maintain or restore patency of the pAVF

    Measured: Assessed up to 5 years

  12. Total Reinterventions

    The total number of reinterventions over the life of the access until abandonment or when the subject exits the study.

    Measured: Assessed up to 5 years

  13. Freedom from Serious Adverse Events

    Defined as the interval of time from access creation to the first occurrence of any serious adverse event.

    Measured: Assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start21 Oct 2025
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07153939
Sponsor's protocol ID
CP0865
Acronym
VENOS-3
Status last verified
Sep 2026
First submitted
20 Aug 2025
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Velocity Percutaneous Arteriovenous Fistula in people with Chronic Kidney Disease and Hemodialysis Access, run by Venova Medical at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shant Vartanian, MD (408-242-5897, Venos-3@venovamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physiologic Maturation (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07153939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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