Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for De Novo Coronary Bifurcation Lesions

Inclusion criteria

• . Age ≥18 years and ≤80 years.
• . Evidence of asymptomatic myocardial ischemia, or stable/unstable angina, or myocardial infarction that occurred more than 7 days before enrollment and is now stable.
• . Suitable for any type of coronary artery revascularization, such as balloon angioplasty, stent implantation, and coronary artery bypass grafting (CABG).
• . Capable of understanding the purpose of the trial, willing to participate, and acknowledging the risks and benefits described in the informed consent document by signing the informed consent form, and willing to undergo invasive imaging follow-up.
• . A maximum of 2 vessels requiring treatment, with no more than 3 lesions in total.
• . If the non-target lesion and the target lesion are in the same vessel, the non-target lesion must be located distal to the target lesion.
• . Successful interventional treatment of the non-target lesion prior to the target lesion.
• . Only one true bifurcation lesion requiring treatment (Medina classification 1.1.1, 1.0.1, 0.1.1), with a diameter stenosis ≥70% (by visual estimation) at the ostium of the target lesion side branch.

Exclusion criteria