Actively Recruiting
Pivotal Study of the Velocity™ pAVF System
Led by Venova Medical · Updated on 2026-01-30
126
Participants Needed
10
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pivotal Study of the Velocity™ pAVF System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years and younger than 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 mm and 5.0 mm
- Proximal radial artery diameter between 2.0 mm and 4.0 mm
- Willing and able to provide written informed consent
- Willing and able to complete all study assessments and follow-up requirements
You will not qualify if you...
- Systolic blood pressure in the study arm less than 100 mmHg
- Blockage or occlusion of the ulnar or radial artery at any level or abnormal Allen's test
- Prior arterio-venous graft or upper arm fistula on the same side as the study arm
- Distance between cubital perforating vein and proximal radial artery greater than 3.0 mm
- Cephalic vein diameter less than 2.5 mm between cubital perforating vein and axillary vein
- Central venous blockage on the same side as the study arm
- Severe calcification of the radial artery that blocks ultrasound imaging
- Active systemic or localized infection near the procedure site in the past 7 days
- Severe heart disease (NYHA class III or IV), recent heart attack within 6 months, ventricular arrhythmias needing treatment, or unstable angina
- Any reason preventing use of antiplatelet therapy
- Currently receiving another investigational device or drug
- Known adverse reactions to sedation or anesthesia that cannot be managed
- Poorly controlled diabetes with HbA1C greater than 10%
- Known blood clotting disorders or bleeding problems
- Lymphedema of the study arm
- Scheduled kidney transplant within 6 months
- Abnormal white blood cell counts or neutrophil percentage
- Low platelet count below 75,000 cells/µL
- Current cancer diagnosis unless in remission for more than 1 year
- Pregnant or breastfeeding
- Allergies to nickel, nickel titanium alloy, or components of the Velocity system
- Any other medical condition that may put participant at risk or affect study results
- Unsuitable vascular anatomy for device use at the intended treatment site as determined by the investigator
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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