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.
Age ≥ 18 years
Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice
End-Stage Renal Disease (ESRD) receiving maintenance hemodialysis.
A forearm cephalic vein segment of ≥ 14 cm in length that provides an approximately 10 cm cannulation zone, free of detectable occlusions or stenosis, with collaterals.
Known allergy to Amplifi System components (polyurethane, nitinol), iodinated contrast agents, heparin, or apixaban
Known or suspected active infection at the proposed time of Amplifi System placement
Known bleeding diathesis, including from uncorrected coagulopathy
Known thrombophilia, requiring treatment
Amplifi Vascular, Inc.
Lead sponsor