Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment

This prospective, single-center, randomized, controlled trial aims to evaluate and compare the differential effects of sirolimus-coated versus paclitaxel-coated drug-coated balloons (DCBs) on local inflammatory responses and plaque healing characteristics in patients with acute coronary syndrome (ACS) with optical coherence tomography (OCT).

Inclusion criteria

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.

Exclusion criteria

Subjects will be excluded if they meet any of the following criteria:

• Total occlusion (TIMI 0 flow) lesion;
• In-stent restenosis lesion;
• Concurrent left main disease or severe three-vessel disease requiring coronary artery bypass grafting;
• Target lesion with severe calcification or tortuosity that cannot be crossed by guidewire;
• Coronary artery bypass graft stenosis;
• Confirmed ST-elevation myocardial infarction;
• Cardiogenic shock or requiring mechanical respiratory and circulatory support;
• Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
• 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;
• 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 conditions deemed unsuitable for enrollment by the investigator.