Morphological Changes of Plaque and Factors Influencing Plaque Healing After Drug-Coated Balloon for de Novo Coronary Lesions: A Optical Coherence Tomography Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Major cardiovascular adverse events rate
研究概览
简要总结
The study aims at evaluating the morphological changes of plaque estimated by optical coherence tomography (OCT) and Factors Influencing Plaque Healing after Drug-Coated Balloon (DCB) for de Novo Coronary Lesions.
详细描述
Percutaneous coronary intervention with a drug-eluting stent (DES) is the most common mode of revascularization for coronary artery disease. However, their efficacy is limited by in-stent restenosis and stent thrombosis. Drug-coated balloon (DCB) deliver an anti-proliferative drug into the vessel wall and leave nothing behind, which is a promising technique in the treatment of coronary artery disease. Previous many studies have confirmed that DCB treatment for de Novo coronary lesions is safe and efficient. But, data about morphological changes of plaque and factors influencing plaque healing after DCB for de Novo Coronary Lesions is scarce. The study compares morphological changes of plaques evaluated by OCT between baseline and 1-year follow-up and evaluates factors influencing plaque healing. All the included patient will receive dual antiplatelet therapy (DAPT) for one month followed by clopidogrel treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Diagnosed as CAD underwent coronary angiography and OCT Examination.
- •Patients with de novo lesion suitable for DCB treatment.
- •The reference diameter of targeted artery ≥2.75mm, the length of targeted lesion ≤25mm.
- •Agreed to accept DCB treatment and written the informed consent.
排除标准
- •Patients with de novo lesion unsuitable for DCB treatment.
- •In-stent restenosis, coronary dissection, coronary spam, thrombus
- •left main artery disease
- •Age>80 years old
- •Cardiogenic shock or stroke admission
- •Severe hepatic or renal dysfunction
- •Poor quality of OCT image or massive thrombus
- •Disagreed to accept DCB treatment.
- •Life expectancy < 1year. Angiographic Exclusion Criteria
- •After pre-dilation of targeted lesions, the patients with residual stenosis>30%, TIMI flow <III grade and presence of major dissection (C type or higher).
结局指标
主要结局
Major cardiovascular adverse events rate
时间窗: 1-year follow-up
In patients treated by DCB, the safety objectives are to evaluate the occurrence of any adverse events in 1 year (re-infarction, re-hospitalization, revascularization by PCI or CABG, cardiac death, stoke, and major bleeding).
次要结局
- Differences in lesion characteristics evaluated by OCT between baseline and follow-up.(1-year follow-up)
- Differences in lipid-plaque characteristics evaluated by OCT between baseline and follow-up in setting of lipid-plaque.(1-year follow-up)
- The incidence of late lumen loss (LLL) at follow-up.(1-year follow-up)
- Differences in OCT-defined characteristics at baseline according to the presence of late lumen loss (LLL) at follow-up.(1-year follow-up)
研究者
Da Yin
The director of the cardiology department
The First Affiliated Hospital of Dalian Medical University