Study of the Amplifi Vein Dilation System for Improving Vein Dilation and Maturation in Patients Needing Arteriovenous Fistula for Dialysis

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the Amplifi12 Vein Dilation System in patients with end-stage renal disease ESRD who need distal arteriovenous fistula AVF creation for hemodialysis. The study includes two groups a randomized controlled cohort of patients with suitable cephalic veins 652.5 mm and a non-randomized cohort with borderline veins 1.7 to <2.5 mm. The trial investigates whether using the Amplifi system improves vein dilation and AVF maturation compared to standard methods. The Amplifi System is a temporary extracorporeal blood pump that delivers controlled blood flow through the cephalic vein for 24 to 72 hours before AVF surgery. Patients with veins 652.5 mm are randomly assigned to either Amplifi treatment plus AVF creation or standard AVF creation alone. Those with borderline veins receive Amplifi treatment followed by AVF creation. The study starts with a small safety cohort and uses standardized surgical and imaging protocols. Participants undergo AVF surgery after Amplifi therapy or standard care, with assessments including duplex ultrasound to measure vein diameter and blood flow two weeks after surgery. Researchers track AVF maturation, functionality, patency, and adverse events up to 12 months. Imaging and safety data are centrally reviewed. The total study duration spans from preoperative treatment through 12 months of follow-up to monitor outcomes and device safety.

Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)