KCT0003325已完成未知
Optical CoherenCe tomography-gUided coronary intervention in Patients with complex lesIons: a randomized controlled trial (OCCUPI trial)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 1,604
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 85(Year)(—)
- 性别
- All
入选标准
- •Age 19-85 years
- •- Patients with ischemic heart diseases (including stable angina, unstable angina and acute myocardial infarction) presented with typical chest pain or objective evidences of myocardial ischemia (positive invasive or non-invasive studies,
- •electrocardiogram (ECG) consistent with ischemia, or elevated cardiac enzymes)
- •- Complex coronary stenotic lesions (>50% based on visual estimate) considered for coronary revascularization with DES
- •- Definition of complex lesions (at least one):
- •? Acute myocardial infarction
- •? Chronic total occlusion
- •? Long lesion: expected stent length =28mm based on angiographic estimation
- •? Calcified lesion
- •? Bifurcation (including all techniques, one- or two-stent)
- •? Unprotected left main disease
- •? Small vessel diseases with reference vessel diameter less than 2.5 mm
- •? Intracoronary thrombus visible on the angiography
- •? Stent thrombosis
- •? In-stent restenosis
- •- Patients who provide signed informed consent
排除标准
- •- Severe hepatic dysfunction (=3 times normal reference values)
- •- Significant renal dysfunction (Serum creatinine >2.0 mg/dL)
- •- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a white blood cell count of <3,000 cells/mm3, hemoglobin <8.0 g/dL, or other known bleeding diathesis
- •- Hemodynamically unstable during procedures or cardiogenic shock
- •- Pregnant women or women who might be pregnant
- •- Life expectancy; less than 1 year
- •- Inability to understand or read the informed content
研究者
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