Drug-coated Balloons Treatment in Chronic Total Occlusion Coronary Artery Disease Guided by Intravascular Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of major adverse cardiovascular events (MACE) in 12 month
研究概览
简要总结
The percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) coronary artery disease is difficult, the success rate is low, and the incidence of re-occlusion and restenosis is high. With the wide application of imaging technology represented by intravascular ultrasound (IVUS), the success rate of CTO PCI has been significantly improved. Drug-coated balloons (DCB), as a treatment without metal implantation, has lower lumen loss and no significant increase in the rate of revascularization. Through IVUS measurement of vascular lumen after CTO opening, appropriate instruments can be selected for adequate dilation, and appropriate treatment methods can be selected according to different lumen structures. Therefore, the purpose of this study was to evaluate the clinical effect of IVUS-guided DCB therapy on CTO lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 18, male or female;
- •Patients who meet the diagnostic criteria for coronary heart disease, have clinical symptoms and seek interventional treatment;
- •Coronary angiography confirmed that the blood vessels met the diagnostic criteria of CTO;
- •Sign informed consent and be willing to undergo follow-up for at least 12 months.
排除标准
- •Patients with severe contrast allergy who cannot tolerate coronary angiography;
- •Patients known allergy to drug balloon coating;
- •Patients who is pregnant or breastfeeding;
- •Bleeding or other diseases, such as digestive tract ulcers, blood system diseases, etc., limit the use of platelet aggregation inhibitors and anticoagulation therapy;
- •Patients with cardiac shock;
- •Patients with a life expectancy of less than 1 year;
- •Other situations deemed unsuitable for inclusion by the researcher.
结局指标
主要结局
Rate of major adverse cardiovascular events (MACE) in 12 month
时间窗: 12 month
cardiovascular death, nonfatal myocardial infarction, and target vessel revascularization
次要结局
- Rate of cardiovascular death in 12 month(12 month)
- Rate of technical success after PCI(1 day)
- Rate of nonfatal myocardial infarction in 12 month(12 month)
- Rate of target vessel revascularization in 12 month(12 month)
- Rate of procedure success rate after PCI(1 day)
- Rate of minor bleeding events(12 month)
- Rate of major bleeding events(12 month)
研究者
Chenpengsheng
principal investigator
Xuzhou Central Hospital