A Pivotal Study to Evaluate the Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and Arteriovenous Fistula Maturation
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.
• 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 occlusions or stenosis, with collaterals.
⁃ Central continuity of the forearm cephalic vein at the elbow demonstrated through one or any combination of the following pathways:
• the upper arm cephalic vein,
∙ the median cubital vein connecting to the upper arm basilic vein,
∙ the perforator vein connecting to the deep venous system.
⁃ Upper arm veins must show central continuity with no detectable occlusions.
• Palpable radial artery with a diameter of ≥ 2.0 mm at the site of proposed AVF creation without significant stenosis along the course
• Positive Allen's Test
• At least one patent internal jugular vein suitable for Amplifi Inflow Catheter insertion
• Subject has voluntarily signed written informed consent