The effectiveness and safety of drug-coated balloon (DCB) have been extensively studied in the treatment of de novo small-vessel coronary lesions. Proper lesion preparation is essential prior to performing DCB angioplasty; however, the optimal approach for intravascular ultrasound (IVUS)-guided lesion preparation remains unclear. The safety and efficacy of IVUS-guided DCB treatment for de novo small-vessel coronary lesions continue to be uncertain. To address these gaps, this trial has been designed to evaluate the efficacy and safety of IVUS-guided DCB angioplasty for de novo small-vessel coronary lesions. Additionally, the trial seeks to establish optimal critical values for IVUS-derived lumen parameters (such as minimum lumen area, plaque burden, and the length and thickness of dissection) prior to the use of DCB for de novo small-vessel coronary lesions.

This trial is designed to test the hypothesis that IVUS-guided DCB results in a lower rate of major adverse cardiac events (MACE) for de novo small-vessel coronary lesions. It is a prospective, multicenter, randomized controlled study involving 998 patients indicated for PCI with de novo coronary lesions suitable for DCB treatment. Participants will be randomly allocated in a 1:1 ratio to either the research group (IVUS-guided group) or the control group (angiography-guided group). The primary endpoint is defined as the incidence of MACE (comprising cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) at the 12-month follow-up. Secondary endpoints include clinical outcomes such as all-cause mortality, any myocardial infarction, or ischemia-driven target vessel revascularization at the 12-month follow-up. Additionally, periprocedural outcomes, including the angiographic success rate, clinical procedural success rate, and target vessel drug-eluting stent implantation rate, will also be assessed.

This clinical trial aims to provide evidence on whether IVUS-guided DCB reduces the incidence of MACE in de novo small-vessel coronary lesions.

© 2025 The Author(s). Published by Elsevier Inc.