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Recruiting
NCT07211035
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
Conditions: End Stage Kidney Disease (ESRD)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 160
Sponsor: Amplifi Vascular, Inc.
Location: Brigham Women's Hospital Boston Massachusetts
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 \
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years
2. Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice
3. End-Stage Renal Disease (ESRD) receiving maintenance hemodialysis.
4. Baseline cephalic vein diameter between \>1.7 mm and \
Source: ClinicalTrials.gov (NCT07211035). StuddyBuddy aggregates publicly available trial information.
