Amplifi Vascular, Inc.
The AMPLIFI-1 Study is a prospective, multicenter pivotal clinical trial designed to evaluate the safety and effectiveness of the Amplifi™ Vein Dilation System in patients requiring distal arteriovenous fistula (AVF) creation for hemodialysis. The study has two cohorts: a randomized controlled (RC) cohort of patients with suitable cephalic veins (≥2.5 mm) randomized 2:1 to Amplifi treatment plus AVF creation versus standard AVF creation alone, and a non-randomized small vein cohort (NRC) of patients with borderline veins (1.7 to \<2.5 mm) treated with Amplifi therapy followed by AVF creation.
AMPLIFI-1 is a staged, multicenter clinical investigation evaluating the safety and effectiveness of the Amplifi™ Vein Dilation System in patients with end-stage renal disease (ESRD) undergoing distal arteriovenous fistula (AVF) creation. The system provides controlled, continuous extracorporeal blood flow to the cephalic vein over 24 to 72 hours, inducing flow-mediated dilation prior to surgery. The study includes two cohorts based on baseline cephalic vein diameter: Randomized Controlled (RC) Cohort: Subjects with vein diameter ≥2.5 mm are randomized 2:1 to receive either Amplifi therapy f…
Inclusion Criteria: 1. Age ≥ 18 years 2. Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice 3. End-Stage Renal Disease (ESRD) receiving maintenance hemodialysis. 4. Baseline cephalic vein diameter between \>1.7 mm and \<3.2 mm at the proposed Study AVF creation site in the distal forearm, with a continuous distal segment or tributary suitable for Amplifi System Outflow Catheter placement, including: * A forearm cephalic vein segment of ≥ 14 cm in length that provides an approximately 10 cm cannulation zone, free of detectable occlusi…
The Amplifi System is a temporary extracorporeal blood pump designed to deliver controlled flow through a peripheral vein for 24-72 hours prior to AVF creation. By increasing wall shear stress, the device promotes physiologic vein dilation, enabling successful creation of a distal radiocephalic arteriovenous fistula (AVF) in patients with small or borderline veins.
Standard of Care AVF creation
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