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临床试验/KCT0003325
KCT0003325已完成未知

Optical CoherenCe tomography-gUided coronary intervention in Patients with complex lesIons: a randomized controlled trial (OCCUPI trial)

Yonsei University Health System, Severance Hospital0 个研究点目标入组 1,604 人开始时间: 待定最近更新:

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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