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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
Stručný súhrn
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.
Základné údaje
| Ochorenia | End Stage Kidney Disease (ESRD) |
|---|---|
| Intervencie |
DEVICE: 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. PROCEDURE: Standard of Care (AVF creation) |
| Sponzor | Amplifi Vascular, Inc. |
| Plánovaný počet | 160 |
| Začiatok | 2026-05-12 |
| Predp. ukončenie (primárne) | 2027-06-01 |
| Krajiny | United States |
| Posledná aktualizácia | 2026-06-23 |