ILLUMENATE assessed the safety and performance of Stellarex drug-coated balloon (DCB) in de novo and restenosis femoropopliteal lesions in a broad patient population. The rigorous 4-year data, building on the ILLUMENATE RCT program, showed favorable safety and efficacy outcomes of the device (8.1% all- cause mortality), and similar efficacy in prespecified cohorts including gender and diabetics. Prior to these findings, there was limited long term-data around all-cause mortality of paclitaxel coated balloons. Freedom from CD-TLR through 4 years was 75.6% showing durable long-term outcomes with this low dose paclitaxel DCB. No mortality signal from DCB therapy emerged during this global study though it was underpowered for mortality.
All Peripheral Clinical Practice
Including recently published studies, coverage of late-breaking science, updates from clinical trials and registries, and complex case presentations.