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AGENT Japan SV is a randomized controlled study that enrolled 150 patients from 14 Japanese sites treated with Agent or SeQuent Please paclitaxel-coated balloon. This study also includes a single-arm substudy evaluating the safety and effectiveness of Agent in patients with in-stent restenosis (ISR). Patients with a single de novo native lesion (lesion length\u2009\u2264\u200928\u00a0mm and reference diameter\u2009\u2265\u20092.00 to \u2009&lt;\u20093.00\u00a0mm) were randomized 2:1 to receive either Agent (<jats:italic>n<\/jats:italic>\u2009=\u2009101) or SeQuent Please (<jats:italic>n<\/jats:italic>\u2009=\u200949). The ISR substudy enrolled 30 patients with lesion length\u2009\u2264\u200928\u00a0mm and reference diameter\u2009\u2265\u20092.00 to \u2009\u2264\u20094.00\u00a0mm. In the SV RCT, target lesion failure (TLF) at 1 year occurred in four patients treated with Agent (4.0%) versus one patient with SeQuent Please (2.0%; <jats:italic>P<\/jats:italic>\u2009=\u20091.00). None of the patients in either treatment arm died. There were no significant differences in the rates of myocardial infarction, target lesion revascularization and target lesion thrombosis through 1 year. In the ISR substudy, the 1-year rates of TLF and target lesion thrombosis were 6.7% and 0.0%, respectively. 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Dr. Ando received honoraria from Terumo, Japan Lifeline, Bristol Myers Squibb, Japan Medtronic, Abbott Medical Japan and Biotronik Japan. Dr. Shite received honoraria from Abbott, Terumo and Nipro. Dr. Ken Kozuma received the honoraria and research and scholarship grants from BSC Japan K.K. Dr. Yamaguchi received honoraria from Abbott and endowments from Abbott, BSC Japan K.K, Medtronic and Terumo. Drs. Underwood and Allocco are full-time employees and shareholders in BSC. Drs. M Nakamura, Isawa, S Nakamura, Namiki, Shibata, Shinke, Ito, Fujii, Saito and Yamazaki have no conflicts of interest to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}