Clinical Trial

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

Study acronym: AMPLIFI-1

Recruiting

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.

Protocol Amendment History 8 changes

critical Recruitment opened 2026-05-21

notable Enrollment increased: 120 -> 160 participants 2026-05-21

critical Trial status changed: Withheld → Not Yet Recruiting 2026-04-30

critical Phase changed: not specified -> not applicable 2026-04-30

critical Primary endpoint(s) modified 2026-04-30

notable Enrollment changed: None -> 120 2026-04-30

notable Sponsor changed: [Redacted] -> Amplifi Vascular, Inc. 2026-04-30

minor Trial arms changed: 0 -> 3 2026-04-30

Trial Details

NCT Number	NCT07211035
Lead Sponsor	Amplifi Vascular, Inc.
Conditions	End Stage Kidney Disease (ESRD)
Enrollment	160 participants
Start Date	2026-05-12
Primary Completion	2027-06-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-23