This multi-phase clinical study evaluated the safety and performance of the Amplifi Vein Dilation System (Amplifi System) in subjects requiring arteriovenous fistula (AVF) creation. Conducted at a single site outside the United States, subjects were enrolled across multiple phases. The study focused on device-related safety, procedural success, percent change in vein dilation and AVF maturation outcomes.
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Rate of AVF Maturation at 2 and 6 Weeks
Timeframe: From post AVF creation to end of 6 weeks follow-up.
Percent Change in Cephalic Vein Diameter and Blood Flow
Timeframe: From baseline, during Amplifi System treatment (minimum daily), and prior to Amplifi System removal and AVF creation]
Mean vein diameter of the cephalic vein and blood flow of brachial artery
Timeframe: 2 and 6 weeks post AVF creation
Percentage of subjects who experience an increase in the cephalic vein diameter of ≥2.7 mm from their baseline measurement, or an increase of >1 mm from baseline, following treatment with the Amplifi System.
Timeframe: From baseline measurement to intra-procedural assessment immediately prior to Amplifi System removal and AVF creation (same procedure day)
Rate of Occurrence of Major Device-Related Adverse Events
Timeframe: from device implantation and up to 30 days from device removal and AVF creation