Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment

Prior treatment

• Concurrent left main disease or severe three-vessel disease requiring coronary artery bypass grafting;
• History of stroke within 6 months prior to enrollment;
• Scheduled elective surgery within 6 months after enrollment requiring discontinuation of anticoagulant or antiplatelet medications;
• Currently participating in other drug or interventional medical device clinical studies;

Other illness

• Confirmed ST-elevation myocardial infarction;
• Severe renal insufficiency or undergoing hemodialysis;
• Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media, paclitaxel, sirolimus and/or other analogues;
• Systemic lupus erythematosus or other systemic autoimmune diseases;
• Other conditions deemed unsuitable for enrollment by the investigator.

Other

• Subjects will be excluded if they meet any of the following criteria:
• Total occlusion (TIMI 0 flow) lesion;
• In-stent restenosis lesion;
• Target lesion with severe calcification or tortuosity that cannot be crossed by guidewire;
• Coronary artery bypass graft stenosis;
• Cardiogenic shock or requiring mechanical respiratory and circulatory support;
• Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;

• Subjects must meet all of the following criteria to be enrolled:
• Age between 18 and 80 years old, both genders eligible;
• Coronary angiography showing non-complex lesions with acute coronary syndrome (non-ST-elevation myocardial infarction and unstable angina) deemed suitable for drug-coated balloon treatment by the investigator;
• Visually estimated lesion length ≤28mm, visually estimated vessel diameter ≥2.5mm and ≤3.0mm;
• Successful lesion pre-dilation (must simultaneously meet all 3 criteria: no Type C or greater dissection; TIMI flow grade 3; visually estimated residual stenosis ≤30%);
• Able to understand the study purpose, willing to complete follow-up visits, and voluntarily provide informed consent.