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

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 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 < 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.