An interventional study of Velocity Percutaneous Arteriovenous Fistula in Chronic Kidney Disease, Hemodialysis Access and Arteriovenous Fistula, sponsored by Venova Medical. Recruiting at 13 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Venova Medical · Not applicable, Interventional, and Treatment
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.
3,145 studies on the registry are indexed under Renal Insufficiency, Chronic; 702 are open to participants now.
This study's planned enrollment of 126 is above the median of 74 across 2,177 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Venova Medical is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: 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.
Also known as: Velocity pAVF
Physiologic Maturation
The proportion of participants that reach the binary outcome of Physiologic Maturation. Physiologic Maturation is a composite measure, reached when Duplex ultrasound demonstrates a brachial artery blood flow of ≥ 500 ml/min and an outflow vein diameter of ≥ 5 mm.
Time frame: 6 weeks
Serious Adverse Device Effect
Any Serious Adverse Event that reasonably suggests is caused by the device or procedure
Time frame: 30 days
Functional Maturation
The number of participants with successful two needle cannulation for 75% of dialysis sessions over a consecutive 4 weeks period following pAVF creation
Time frame: 6 months
Unassisted Functional Maturation
The number of participants that reach functional maturation without any endovascular or surgical interventions to facilitate maturation and/or manage complications
Time frame: 6 months
Physiologic Maturation
The proportion of participants that reach the binary outcome of Physiologic Maturation. Physiologic Maturation is a composite measure, reached when Duplex ultrasound demonstrates a brachial artery blood flow of ≥ 500 ml/min and an outflow vein diameter of ≥ 5 mm.
Time frame: 3 months
Time to First Hemodialysis
The interval from the time of pAVF creation to the first hemodialysis session using 2-needles in the ESRD subgroup
Time frame: Through 12 month follow up, on average at 3 months
Number of Catheter Days
The number of days from pAVF creation to central venous catheter removal in the ESRD subgroup.
Time frame: Through 12 month follow up, on average at 3 months
Access Circuit Primary Patency
The interval of time from access creation until the first occurrence of any reintervention to maintain or reestablish patency or until access thrombosis or abandonment.
Time frame: Assessed up to 5 years
Velocity pAVF Primary Patency
The interval of time from access creation until the first occurrence of reintervention or thrombosis directly attributable to a causative lesion within 5 mm of each end of the Velocity pAVF.
Time frame: Assessed up to 5 years
Access Circuit Cumulative Patency
The interval of time from access creation until the final abandonment of the access, inclusive of all successful interventions to maintain or restore patency
Time frame: Assessed up to 5 years
Technical Success
The proportion of subjects with successful delivery of the implant between the perforating cubital vein and the radial artery, and removal of the delivery system, at the index procedure.
Time frame: Immediately after the intervention
Procedural Success
The proportion of subjects with intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein
Time frame: Immediately after the intervention
Freedom from Reintervention
The duration from the time of access creation until the first occurrence of a reintervention required to maintain or restore patency of the pAVF
Time frame: Assessed up to 5 years
Total Reinterventions
The total number of reinterventions over the life of the access until abandonment or when the subject exits the study.
Time frame: Assessed up to 5 years
Freedom from Serious Adverse Events
Defined as the interval of time from access creation to the first occurrence of any serious adverse event.
Time frame: Assessed up to 5 years
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Venova Medical