Role of CT Scan for the Successful Recanalization of Chronic Total Occlusion; a Randomized Comparison Between 3D CT-guided PCI vs. Conventional Treatment (CT-CTO Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Successful CTO recanalization
研究概览
简要总结
The revascularization of chronic total occlusion of coronary arteries (CTO) is the most challenging procedure for the coronary intervention. For the initial period for CTO intervention, percutaneous coronary artery intervention (PCI) of CTO lesions are associated with low procedural success rates about 70%. Recently, the success rate of the recanalization of CTOs has been raised in several studies.
Coronary CT angiography (CCTA) is an effective noninvasive diagnostic modality for detecting coronary artery disease. CCTA can visualize the complete anatomy of coronary arteries in contrast to conventional coronary angiography, reducing the deferral rates from CTO intervention. Assessment of characteristics of CTO lesions by pre-procedural CCTA could help to determine revascularization strategy and estimate the procedure time, leading to lower procedural complications. We suggest that success rates and clinical outcome of intervention of CTO lesion can be improved by pre-procedural CCTA.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (age >19 years) with CTO (TIMI = 0 and estimated duration of occlusion at least 3 months)
- •Typical symptomatic angina or positive stress test in various functional studies evaluating ischemia
- •Eligible patients for pre-procedural CT scan and coronary angiogram
排除标准
- •Cardiogenic shock or ejection fraction < 25%
- •CTO lesions at DES restenosis or graft occlusion lesion
- •Significant left main stenosis
- •Retry of same CTO lesion within 2 weeks
- •Acute myocardial infarction within 48 hours
- •Hypersensitivity to aspirin, clopidogrel, or -limus families / or contraindication to antiplatelet agents
- •Severe hepatic dysfunction (≥3 times normal reference values)
- •Life expectancy < 1 years
- •Pregnant women or women with potential childbearing
结局指标
主要结局
Successful CTO recanalization
时间窗: Immediately after CTO PCI
Incidence of the successful CTO recanalization between pre-PCI CT scan group versus control group
次要结局
- Incidence of MACEs(12 months after index PCI)