Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
NCT07211035
This study is recruiting at 2 US sites in 2 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- End Stage Kidney Disease (ESRD)
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Amplifi Vascular, Inc.
- Last updated on ClinicalTrials.gov
- June 23, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Massachusetts · 1
- Brigham Women's Hospital · Boston, MA
Texas · 1
- Flow Vascular · Houston, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.