Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
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
- Comparison of the difference in minimal lumen diameter (MLD) between two groups
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of drug-coated balloon angioplasty for the treatment of chronic total occlusions patients with chronic total occlusion (CTO) lesion.
详细描述
Recruited CTO patients will be divided into two groups: those undergoing PCI of drug-coated balloon (DCB group), and those undergoing PCI of drug eluting stent implantation (DES group). The primary outcome assessed will be the late lumen loss evaluation at a 12-month of follow-up appointment. Secondary outcomes include occurrence of major cardiac events (MACEs), myocardial viability, operate success, quality of life changes which will be compared to a baseline measurement.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DCB group
Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions
干预措施: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor (Drug)
DCB group
Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions
干预措施: coronary wires. or coronary balloons (Device)
DCB group
Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions
干预措施: drug-coated balloon (Other)
DES group
Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions
干预措施: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor (Drug)
DES group
Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions
干预措施: coronary wires. or coronary balloons (Device)
DES group
Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions
干预措施: drug-eluting stent (Device)
结局指标
主要结局
Comparison of the difference in minimal lumen diameter (MLD) between two groups
时间窗: 12 months
Measured by Intravascular ultrasound (IVUS) or optical coherence tomography (OCT)
次要结局
- Comparison of the incidence of major adverse cardiac events（MACEs） between two groups(12 months)
- Comparison of myocardial viability (late gadolinium enhancement, LGE) in the territory supplied by the CTO artery between two groups evaluated via cardiovascular magnetic resonance (CMR)(12 months)
研究者
Xiantao Song, MD
Professor
Beijing Anzhen Hospital