Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
126 participants
INTERVENTIONAL
2025-10-21
2030-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Velocity Percutaneous Arteriovenous Fistula
The Velocity pAVF is a catheter-based device used to create an arteriovenous fistula for hemodialysis access through a minimally invasive, percutaneous procedure. Unlike surgical AVF creation or other pAVF systems, Velocity is designed to simplify the procedure and improve consistency of maturation and long-term function. All participants in this study will undergo AVF creation using the Velocity pAVF.
Interventions
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Velocity Percutaneous Arteriovenous Fistula
The Velocity pAVF is a catheter-based device used to create an arteriovenous fistula for hemodialysis access through a minimally invasive, percutaneous procedure. Unlike surgical AVF creation or other pAVF systems, Velocity is designed to simplify the procedure and improve consistency of maturation and long-term function. All participants in this study will undergo AVF creation using the Velocity pAVF.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm
3. Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm
4. Age \> 18 years and \< 80 years
5. Willing and competent to give written informed consent
6. Willing and able to complete all study assessments and follow-up requirements
Exclusion Criteria
2. Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
3. Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF.
4. Distance between Cubital Perforating Vein and Proximal Radial Artery \> 3.0 mm
5. Cephalic vein diameter \< 2.5 mm at any point from the CPV to the axillary vein
6. Central venous occlusion ipsilateral of the study extremity
7. Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment.
8. Evidence of active systemic infections or localized to the procedure access site within the past 7 days
9. 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
10. Any contraindication to antiplatelet therapy
11. Currently being treated with another investigational device or drug
12. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
13. Uncontrolled or poorly controlled diabetes defined as a HbA1C \> 10%
14. Known hypercoagulable condition, bleeding diathesis or coagulation disorder
15. Lymphedema of the study extremity
16. Scheduled kidney transplant within 6 months of enrollment
17. Peripheral white blood cell count \< 1,500 cells/μL or \> 13,000 cells/μL and neutrophil \> 80%
18. Platelet count \< 75,000 cells/ μL
19. Current diagnosis of carcinoma (unless in remission \> 1 year)
20. Pregnant or currently breast feeding
21. Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System
22. 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
23. Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.
18 Years
80 Years
ALL
No
Sponsors
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Venova Medical
INDUSTRY
Responsible Party
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Locations
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Trinity Research Group
Dothan, Alabama, United States
West Coast Kidney Institute Concord
Concord, California, United States
Apex Research
Riverside, California, United States
Vascular and Embolization Specialists
Cocoa, Florida, United States
Azura Vascular Care Jacksonville
Jacksonville, Florida, United States
Surgical Specialists of Charlotte
Charlotte, North Carolina, United States
Aqua Research
Houston, Texas, United States
Humble Vascular Surgical Center
Humble, Texas, United States
Fresenius Vascular Care San Antonio
San Antonio, Texas, United States
San Antonio Surgical Center
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Other Identifiers
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CP0865
Identifier Type: -
Identifier Source: org_study_id
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