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Seventy-six patients were enrolled and 73 were included in primary analysis across nine Japanese sites. The study assessed procedural success based on lesion crossing, absence of residual indentation, and \u003C50% residual stenosis by quantitative coronary angiography.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/a-pivotal-study-on-the-novel-cutting-balloon-kcb01-in-patients-with-coronary-artery-disease/460562/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/a-pivotal-study-on-the-novel-cutting-balloon-kcb01-in-patients-with-coronary-artery-disease/460562.png","ImageObject",300,407,{"name":92,"@type":93},"Olivia Brown","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-02","2026-09-30",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",11,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"What is KCB01 (KIZASHI™) in this study?","Question",{"text":113,"@type":114},"KCB01 is a novel cutting balloon catheter with blades integrally formed with the balloon, designed to improve lesion delivery and crossability while maintaining dilation capacity.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"Who were the participants and how was the study conducted?",{"text":118,"@type":114},"The study was prospective, open-label, single-arm, conducted at nine sites in Japan. 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It is designed to overcome the drawbacks of conventional cutting balloons in terms of lesion delivery, crossability and procedural complications while maintaining the same dilation capacity. To evaluate the efficacy and safety of the KCB01, a prospective, open-label, single-arm study was conducted at nine sites in Japan on percutaneous coronary intervention-eligible patients with stenotic lesions that exhibited residual indentation even after conventional balloon dilation at nominal pressure. Seventysix patients were enrolled between November 2022 and June 2023, and 73 eligible patients were included in the primary analysis. The mean age was 73.5 ± 7.4 years, and 79.5% of the patients were male. The target lesion characteristics included bifurcation lesions (42.5%), in-stent restenosis lesions (20.5%), and severely calcified lesions (54.8%). The primary endpoint was procedural success, defined as the KCB01 crossing the target lesion, no residual indentation, and \u003C 50% residual stenosis rate after KCB01 dilation (assessed using quantitative coronary angiography) . The angiographic images obtained during the procedure were evaluated in a core laboratory. The procedural success rate was 87.7%(95% confidence interval [CI]: 77.9–94.2), with the lower limit of the 95% CI (77.9%) exceeding the performance goal of 76.5% . Clinical success rate was achieved in 94.5% of cases (95% CI: 86.6–98.5%), with no major adverse cardiac events reported until discharge. Furthermore, no device deficiencies related to the KCB01 were observed. These results suggest the safety and efficacy of the KCB01 .  \n*  \n1  \n2  \n3  \n4  \n5  \n6  \nMasato Nakamura  \n[masato@oha.toho-u.ac.jp](masato@oha.toho-u.ac.jp)  \nDepartment of Cardiology, Miyazaki Medical Association Hospital, Miyazaki, Japan  \nDepartment of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan  \nCardiovascular Center, Kyoto Katsura Hospital, Kyoto, Japan Department of Cardiology, Tokushima Red Cross Hospital, Tokushima, Japan  \nDepartment of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan  \nDepartment of Cardiology, Fujita Health University Hospital, Aichi, Japan  \n7 Department of Cardiology, Kindai University Hospital, Osaka, Japan  \n8 Department of Cardiology, Cardiovascular Center, Shin-Koga Hospital, Fukuoka, Japan  \n9 Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Saitama, Japan  \n10 Medical Solutions Vehicle, Kaneka Corporation, Osaka, Japan  \n11 Division of Minimally Invasive Treatment in Cardiovascular Medicine, Toho University Ohashi Medical Center, 2-22-36, Ohashi, Meguro-Ku, Tokyo 153-8515, Japan  \nGraphical abstract  \nStudy design  \nProspective, multicenter, single-arm, open-label study  \nFollowed-up until discharge  \n76 patients with stenotic lesion that remained indentation after conventional balloon dilation were enrolled.  \n73 eligible patients were included in the primary analysis.  \nPerformance goal  \n􀀞 Efficacy endpoints  \nProcedural success 87.7%(95%CI 77.9-94.2) KCB01 cross the lesion  \nClinical success 94.5%(95%CI 86.6-98.5)  \nDefinition No residual indentation  \n\u003C50% residual stenosis rate after KCB01 dilation (QCA)  \nSuccessful dilation with KCB01  \nDefinition \u003C50% residual stenosis at the end of the procedure (QCA) No MACE until di","cbCaiorwSM04lbk2","https://ap.wps.com/l/cbCaiorwSM04lbk2","pdf",864917,"English","# Abstract\n## Study design and population\n## Endpoints and definitions\n## Results","[{\"question\":\"What is KCB01 (KIZASHI™) in this study?\",\"answer\":\"KCB01 is a novel cutting balloon catheter with blades integrally formed with the balloon, designed to improve lesion delivery and crossability while maintaining dilation capacity.\"},{\"question\":\"Who were the participants and how was the study conducted?\",\"answer\":\"The study was prospective, open-label, single-arm, conducted at nine sites in Japan. Patients were eligible for PCI and had stenotic lesions with residual indentation after conventional balloon dilation.\"},{\"question\":\"How was procedural success defined?\",\"answer\":\"Procedural success required KCB01 crossing the target lesion, no residual indentation, and a \\u003c50% residual stenosis rate after KCB01 dilation assessed using quantitative coronary angiography.\"}]","A pivotal study on the novel cutting balloon KCB01 in patients with coronary artery disease | PDF",1790758768,28]