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(2) January 25, 2021 Two major randomized controlled trials (RCTs) show no difference in mortality between patients treated with the Philips Stellarex drug-coated balloon (DCB) and those treated with percutaneous angioplasty (PTA), the current standard of care Amsterdam, the Netherlands - Royal Philips). The ILLUMENATE EU RCT and ILLUMENATE Pivotal RCT together comprised approximately 600 patients in Europe and the U.S. After five years, the ILLUMENATE EU RCT showed 19.3% mortality among patients treated with the Stellarex DCB compared to 19.4% mortality for those treated with PTA. The five-year results for the ILLUMENATE Pivotal study also show no statistically significant difference among patients treated with the Stellarex DCB (21.2%) compared to those treated with PTA (20.2%). Both studies had a high vital status follow-up compliance, with the status of over 90% of patients known. ....
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