A pivotal study on the novel cutting balloon KCB01 in patients with coronary artery disease.

ABSTRACT: The KCB01 (KIZASHI^™) is a novel cutting balloon catheter with blades integrally formed with the balloon. 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. Seventy-six 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 th

SUBMITTER: Shibata Y 

PROVIDER: S-EPMC12783245 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature