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.
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
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
Single group
Velocity Percutaneous Arteriovenous Fistula
DeviceThe 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.
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.
Serious Adverse Device Effect
Any Serious Adverse Event that reasonably suggests is caused by the device or procedure
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
Unassisted Functional Maturation
The number of participants that reach functional maturation without any endovascular or surgical interventions to facilitate maturation and/or manage complications
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 to First Hemodialysis
The interval from the time of pAVF creation to the first hemodialysis session using 2-needles in the ESRD subgroup
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