Actively Recruiting
Multicenter Pivotal Study of the Velocity10 Percutaneous Arterio-Venous Fistula System
Led by Venova Medical · Updated on 2026-01-30
126
Participants Needed
10
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method to create dialysis access for people with kidney failure. Dialysis depends on a reliable arteriovenous fistula (AVF), which is usually made through surgery involving incisions and longer recovery. This pivotal study aims to assess the safety and performance of the Velocity System, which forms an AVF through a small skin puncture using a catheter instead of open surgery. All participants will receive the Velocity pAVF procedure in this single-arm, open-label study. The procedure involves creating the AVF using the catheter-based Velocity device. After the procedure, participants will be monitored with physical exams, duplex ultrasound, and dialysis assessments to check fistula maturation, usability for hemodialysis, and long-term function. Any additional procedures needed to help maturation or maintain the access will be recorded. Safety will be closely tracked throughout the study. Participants will be followed for up to five years with regular exams and assessments. Researchers will measure physiologic and functional maturation of the fistula, success of the procedure, time to first hemodialysis, catheter use days, patency of the access circuit, and safety outcomes including device or procedure complications. The study will also document reinterventions and adverse events. The total participation time may extend up to five years to fully evaluate the device's long-term use and safety.
CONDITIONS
Brief Title
Pivotal Study of the Velocity™ pAVF System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 18 and under 80 years
- End stage renal disease requiring hemodialysis access or chronic kidney disease with expected need for hemodialysis within 6 months
- Cubital perforating vein diameter between 2.0 and 5.0 millimeters
- Proximal radial artery diameter between 2.0 and 4.0 millimeters
- Willing and competent to provide written informed consent
- Willing and able to complete all study assessments and follow-up requirements
You will not qualify if you...
- Study arm systolic blood pressure less than 100 mmHg
- Occlusion of the ulnar or radial artery at any level or abnormal Allen's test
- Previous arterio-venous graft or upper arm AVF on the same side
- Distance between cubital perforating vein and proximal radial artery greater than 3.0 mm
- Cephalic vein diameter less than 2.5 mm from the cubital perforating vein to the axillary vein
- Central venous occlusion on the study side
- Severe calcification of the radial artery impairing ultrasound visualization
- Active systemic infection or infection at procedure site within past 7 days
- Severe cardiac disease or recent myocardial infarction
- Contraindication to antiplatelet therapy
- Current treatment with another investigational device or drug
- Known adverse effects to sedation or anesthesia that cannot be managed
- Uncontrolled diabetes (HbA1c over 10%)
- Known blood clotting or bleeding disorders
- Lymphedema of study arm
- Scheduled kidney transplant within 6 months
- Abnormal white blood cell or platelet counts
- Current cancer diagnosis unless in remission over 1 year
- Pregnant or breastfeeding
- Allergies to nickel or components of the Velocity device
- Any condition the investigator believes would risk the participant or affect study data
- Vascular anatomy unsuitable for device use before needle access attempt
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo creation of a dialysis access using the Velocity Percutaneous Arteriovenous Fistula (pAVF), a minimally invasive catheter-based procedure to create an arteriovenous fistula for hemodialysis.
1 visit (in-person)
Duration - Up to 5 years
Participants are monitored with physical examinations, duplex ultrasound, and dialysis assessments to evaluate fistula maturation, usability for hemodialysis, and long-term function. Additional procedures may be performed if needed to assist maturation or maintain access function. Safety monitoring includes assessment of device- and procedure-related complications.
Multiple visits over 5 years for follow-up assessments
Trial Site Locations
Total: 10 locations
1
Trinity Research Group
Dothan, Alabama, United States, 36301
Actively Recruiting
2
West Coast Kidney Institute Concord
Concord, California, United States, 94520
Actively Recruiting
3
Apex Research
Riverside, California, United States, 92505
Actively Recruiting
4
Vascular and Embolization Specialists
Cocoa, Florida, United States, 32926
Actively Recruiting
5
Azura Vascular Care Jacksonville
Jacksonville, Florida, United States, 32218
Actively Recruiting
6
Surgical Specialists of Charlotte
Charlotte, North Carolina, United States, 28207
Actively Recruiting
7
Aqua Research
Houston, Texas, United States, 77058
Actively Recruiting
8
Humble Vascular Surgical Center
Humble, Texas, United States, 77338
Actively Recruiting
9
Fresenius Vascular Care San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
10
San Antonio Surgical Center
San Antonio, Texas, United States, 78216
Actively Recruiting
Research Team
S
Shant Vartanian, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here