Pivotal Study of the Velocity™ pAVF System

NCT07153939 | Recruiting DMC FDA Device

• 1 other identifier: CP0865
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Hemodialysis Access; Arteriovenous Fistula; Chronic Kidney Disease; End Stage Renal Disease (ESRD)

Keywords

percutaneous AVF; pAVF; endovascular AVF; endoAVF; Arteriovenous Fistula; AVF; VENOS-3; VENOS3

Outcome Measures

Primary Outcomes (2)

• 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.

  6 weeks

• Serious Adverse Device Effect

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

  30 days

Secondary Outcomes (13)

• Functional Maturation

  6 months

• Unassisted Functional Maturation

  6 months

• Physiologic Maturation

  3 months

• Time to First Hemodialysis

  Through 12 month follow up, on average at 3 months

• Number of Catheter Days

  Through 12 month follow up, on average at 3 months

Study Arms (1)

Velocity pAVF System Treatment Arm

EXPERIMENTAL

Participants 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.

Device: Velocity Percutaneous Arteriovenous Fistula

Interventions

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.

Also known as: Velocity pAVF

Velocity pAVF System Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Venova Medical: lead

Study Sites (10)

Trinity Research Group

Dothan, Alabama, 36301, United States

RECRUITING

West Coast Kidney Institute Concord

Concord, California, 94520, United States

RECRUITING

Apex Research

Riverside, California, 92505, United States

RECRUITING

Vascular and Embolization Specialists

Cocoa, Florida, 32926, United States

RECRUITING

Azura Vascular Care Jacksonville

Jacksonville, Florida, 32218, United States

RECRUITING

Surgical Specialists of Charlotte

Charlotte, North Carolina, 28207, United States

RECRUITING

Aqua Research

Houston, Texas, 77058, United States

RECRUITING

Humble Vascular Surgical Center

Humble, Texas, 77338, United States

RECRUITING

Fresenius Vascular Care San Antonio

San Antonio, Texas, 78207, United States

RECRUITING

San Antonio Surgical Center

San Antonio, Texas, 78216, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Arteriovenous Fistula; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Central Study Contacts

Shant Vartanian, MD

CONTACT

408-242-5897; Venos-3@venovamed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 4, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2030
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Request for data will be accepted after study completion and final publication of results.

Locations

US (10)