Efficacy and Safety of Sirolimus-Coated Spiral Balloon for Coronary Bifurcation Lesions

Inclusion Criteria: * Patients aged between 18 and 85 years, regardless of gender. * Patients must voluntarily participate in the study and sign an informed consent form. * Patients must demonstrate sufficient adherence to the study protocol and agree to follow-up visits at 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) post-procedure, with angiography required at 9 months (±30 days). * Patients must have evidence of myocardial ischemia. * Angiographically confirmed primary coronary bifurcation lesions (Medina classification non-0, 0, 1) with branch stenosis ≥70% (estimated visually). * Patients suitable for PCI where the branch lesion is not expected to require stenting; stenting is planned for the main vessel, with DCB used on the branch. It is recommended to treat the branch with DCB first, followed by main vessel stenting. * Residual stenosis ≤50% after pre-treatment of the branch lesion, TIMI 3 flow, with no dissection or only A or B grade dissection. C grade dissections should be carefully considered by the investigator before deciding, and are generally not included. * The diameter of the branch vessel must be between 2.0 mm and 4.0 mm, with a lesion length ≤40 mm. Exclusion Criteria: * Patients with bleeding disorders or active gastrointestinal ulcers, those who have had a stroke within the past 6 months, or those who are expected to be intolerant to dual antiplatelet therapy post-intervention. * Patients with severe renal insufficiency (creatinine level \> 3.0 mg/dL or 265.2 µmol/L) and/or end-stage renal disease requiring dialysis. * Patients in cardiogenic shock. * Patients who have experienced a myocardial infarction within the week prior to enrollment. * Patients with severe congestive heart failure or NYHA class IV severe heart failure. * Patients with severe valvular heart disease. * Patients who have undergone heart transplantation. * Patients with a life expectancy of less than 1 year. * Patients currently participating in other drug or device clinical trials that have not yet reached the primary endpoint. * Patients with contraindications to taking aspirin and/or clopidogrel and/or ticagrelor. * Patients known to be allergic to paclitaxel, rapamycin, contrast agents, etc. * Pregnant or breastfeeding women, those with plans to conceive within the year, or those unwilling to use effective contraception. * Target vessels that are completely occluded, severely calcified, have \>45° angulation, or are non-protected left main lesions. * Non-target lesions that cannot be treated prior to or fail to be treated successfully before addressing the target lesion. * Target lesions in branch vessels that are in-stent restenosis. * Other patients deemed unsuitable for inclusion by the investigator.