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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Trinity Research Group
RECRUITING
Dothan
California
Apex Research
RECRUITING
Riverside
Florida
Vascular and Embolization Specialists
RECRUITING
Cocoa
Azura Vascular Care Jacksonville
RECRUITING
Jacksonville
North Carolina
Surgical Specialists of Charlotte
NOT_YET_RECRUITING
Charlotte
Texas
Aqua Research
RECRUITING
Houston
Fresenius Vascular Care San Antonio
RECRUITING
San Antonio
San Antonio Surgical Center
RECRUITING
San Antonio
Contact Information
Primary
Shant Vartanian, MD
Venos-3@venovamed.com
408-242-5897
Time Frame
Start Date: 2025-10-21
Estimated Completion Date: 2030-09
Participants
Target number of participants: 126
Treatments
Experimental: Velocity pAVF System Treatment Arm
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.
Sponsors
Leads: Venova Medical

This content was sourced from clinicaltrials.gov