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