Comparison Study of Sirolimus-Coated Versus Paclitaxel-Coated Coronary Drug-Coated Balloons in the Treatment of Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Optical coherence tomography assessment of target lesion healing and repair at 3-month follow-up after the procedure
研究概览
简要总结
This study aims to investigate and compare the local inflammatory responses and plaque healing characteristics between sirolimus-coated and paclitaxel-coated coronary drug-coated balloons in patients with acute coronary syndrome.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sirolimus-coated DCB group
Treatment of sirolimus-coated DCB
干预措施: Sirolimus-coated DCB (Device)
Paclitaxel-coated DCB
Treatment of paclitaxel-coated DCB
干预措施: Paclitaxel-coated DCB (Device)
结局指标
主要结局
Optical coherence tomography assessment of target lesion healing and repair at 3-month follow-up after the procedure
时间窗: 3 months
OCT assessment of target lesion healing based on three morphological criteria: fibrous cap thickness (FCT), maximum lipid arc, and macrophage infiltration. Target lesion is defined as unhealed if any of the following criteria are met: (1) FCT \<75μm, (2) maximum lipid arc \>180°, or (3) presence of macrophage infiltration. Target lesion is defined as healed only if all three criteria are met: (1) FCT ≥75μm; (2) maximum lipid arc ≤180°; (3) absence of macrophage infiltration. The primary outcome is reported as the proportion of patients with healed target lesions.
次要结局
- OCT-measured minimum lumen area change at 3 months post-procedure(3 months)
- OCT-measured fibrous cap thickness change at 3 months post-procedure(3 months)
- OCT-measured maximum lipid arc change at 3 months post-procedure(3 months)
- OCT assessment of macrophage infiltration change at 3 months post-procedure(3 months)
- OCT-measured thin-cap fibroatheroma count change at 3 months post-procedure(3 months)
- OCT-measured lipid pool length change at 3 months post-procedure(3 months)
- OCT assessment of microchannel change at 3 months post-procedure(3 months)
- OCT-measured minimum lumen diameter change at 3 months post-procedure(3 months)
- CCTA-measured perivascular fat attenuation index change at 6 months(6 months)
- CCTA-measured low-attenuation plaque volume change at 6 months post-procedure(6 months)
- CCTA-measured plaque burden change at 6 months post-procedure(6 months)
- Incidence of target lesion failure (TLF) at 6 months post-procedure(6 months)
- Incidence of patient-oriented composite endpoint (PoCE) at 6 months post-procedure(6 months)