Pivotal Study of the Velocity™ pAVF System

Recruiting now · Not applicable

Conditions studied: Chronic Kidney Disease, Hemodialysis Access, Arteriovenous Fistula, End Stage Renal Disease (ESRD)

In brief

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.

Key facts

Study ID

NCT07153939

Run by

Venova Medical

People needed

126

Starts

2025-10-21

Expected to finish

2030-09-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• 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.

Where it is running

• Trinity Research Group — Dothan, Alabama, United States (enrolling)
• West Coast Kidney Institute Concord — Concord, California, United States (enrolling)
• Apex Research — Riverside, California, United States (enrolling)
• Vascular and Embolization Specialists — Cocoa, Florida, United States (enrolling)
• Azura Vascular Care Jacksonville — Jacksonville, Florida, United States (enrolling)
• Staten Island University Hospital Northwell Health — Staten Island, New York, United States (enrolling)
• Surgical Specialists of Charlotte — Charlotte, North Carolina, United States (enrolling)
• MUSC Health Orangeburg- Dialysis Access Institute — Orangeburg, South Carolina, United States (enrolling)
• Aqua Research — Houston, Texas, United States (enrolling)
• Humble Vascular Surgical Center — Humble, Texas, United States (enrolling)
• Fresenius Vascular Care San Antonio — San Antonio, Texas, United States (enrolling)
• San Antonio Surgical Center — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.