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
Parallel
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.
DeviceThe 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)
Procedure/SurgeryStandard of Care AVF creation
Physiologic AVF Maturation - RC (Amplifi vs Control)
Proportion of RC subjects meeting physiologic maturation by duplex ultrasound, defined as cephalic vein diameter ≥ 5.0 mm and brachial artery flow ≥ 500 mL/min. Primary effectiveness comparison is Amplifi + AVF vs Standard AVF (control) in the RC.
Physiologic AVF Maturation - NRC (Non-Inferiority vs RC Control)
Proportion of NRC subjects meeting the same physiologic maturation definition (diameter ≥ 5.0 mm and flow ≥ 500 mL/min), analyzed for non-inferiority against the RC control arm using a prespecified NI margin (e.g., -20% absolute).
Incidence of Major Device- or Procedure-Related Adverse Events
Proportion of subjects experiencing at least one major device- or procedure-related adverse event (MAE) within 30 days of AVF surgery following Amplifi treatment.
Functional AVF Maturation
Proportion of subjects achieving functional use for hemodialysis, defined as successful two-needle cannulation at prescribed blood flow for ≥ 75% of sessions over a consecutive 4-week period.
Time to Catheter-Free Dialysis
Days from AVF surgery to first successful dialysis using the study AVF without a central venous catheter.
Total Number of Interventions Required to Achieve and Maintain Functional and Secondary Patency
otal count of endovascular or surgical interventions required to achieve and maintain both functional and secondary AVF patency. Interventions may include angioplasty, thrombectomy, surgical revision, or other procedures intended to restore or maintain access patency.
Proportion of AVFs Maintaining Secondary Patency
Proportion of AVFs that remain patent, with or without intervention, at 6 and 12 months following surgical creation. Secondary patency is defined as continued functional access use until abandonment, thrombosis, or surgical revision that precludes further use.
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