Condition: End Stage Kidney Disease (ESRD) · Sponsor: Amplifi Vascular, Inc.
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.
This description comes directly from the study's public registry record.
Erdie De Peralta Vice President, Regulatory and Clinical Affairs, Master of Arts · 19784080949 · edeperalta@amplifivascular.com
Always discuss trial participation with your own doctor first.
| Brigham Women's Hospital | Boston, Massachusetts, United States | Recruiting |
| Flow Vascular | Houston, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07211035