RecruitingNot ApplicableNCT07211035

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

A Pivotal Study to Evaluate the Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and Arteriovenous Fistula Maturation

Sponsor

Amplifi Vascular, Inc.

Enrollment

160 participants

Start Date

May 12, 2026

Study Type

INTERVENTIONAL

Conditions

End Stage Kidney Disease (ESRD)

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Standard of Care (AVF creation) and a medical device called 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. for people with end stage kidney disease (esrd). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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.

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.

PROCEDUREStandard of Care (AVF creation)

Standard of Care AVF creation