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NCT Number: NCT07153939

Pivotal Study of the Velocity™ pAVF 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.

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.

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Key information

Conditions

Chronic Kidney Disease Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes End Stage Renal Disease (ESRD) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Hemodialysis Access Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trinity Research Group, Dothan, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Velocity Percutaneous Arteriovenous Fistula

Device

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.

Other names: Velocity pAVF

Primary outcomes

  1. Physiologic Maturation

    Time frame: 6 weeks

    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.

  2. Serious Adverse Device Effect

    Time frame: 30 days

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

Secondary outcomes

  1. Functional Maturation

    Time frame: 6 months

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

  2. Unassisted Functional Maturation

    Time frame: 6 months

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

  3. Physiologic Maturation

    Time frame: 3 months

    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.

  4. Time to First Hemodialysis

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

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

  5. Number of Catheter Days

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

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

  6. Access Circuit Primary Patency

    Time frame: Assessed up to 5 years

    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.

  7. Velocity pAVF Primary Patency

    Time frame: Assessed up to 5 years

    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.

  8. Access Circuit Cumulative Patency

    Time frame: Assessed up to 5 years

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

  9. Technical Success

    Time frame: Immediately after the intervention

    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.

  10. Procedural Success

    Time frame: Immediately after the intervention

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

  11. Freedom from Reintervention

    Time frame: Assessed up to 5 years

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

  12. Total Reinterventions

    Time frame: Assessed up to 5 years

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

  13. Freedom from Serious Adverse Events

    Time frame: Assessed up to 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Shant Vartanian, MD

CONTACT

[email protected]

408-242-5897

Sponsors and collaborators

Lead sponsor

Venova Medical

Industry

Registry information

Official study title

Multicenter Pivotal Study of the Velocity™ Percutaneous Arterio-Venous Fistula System

Acronym: VENOS-3

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Sep 4, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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