Status:
RECRUITING
Pivotal Study of the Velocity™ pAVF System
Lead Sponsor:
Venova Medical
Conditions:
Chronic Kidney Disease
Hemodialysis Access
Eligibility:
All Genders
18-80 years
Phase:
NA
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,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT07153939
Start Date
October 21 2025
End Date
September 1 2030
Last Update
December 12 2025
Active Locations (8)
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1
Trinity Research Group
Dothan, Alabama, United States, 36301
2
Apex Research
Riverside, California, United States, 92505
3
Vascular and Embolization Specialists
Cocoa, Florida, United States, 32926
4
Azura Vascular Care Jacksonville
Jacksonville, Florida, United States, 32218