Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,604
- 试验地点
- 1
- 主要终点
- Composite of major adverse cardiac events (MACEs)
研究概览
简要总结
There is no definite conclusive work about the benefit of OCT-guided PCI, which should be determined in complex PCI, assuming better stent optimization by OCT. In the study, we will explore the clinical implication of OCT-guided PCI of complex lesions.
详细描述
Eligible patients will be randomly assigned to either OCT-guided PCI arm and angiography-guided PCI with routine high pressure NC ballooning arm in 1:1 ratio. Within OCT-guided PCI arm, the use of OCT will be also assigned to full OCT-guidance arm and postprocedural OCT only arm. and comparison of stent implantation with and without preprocedural OCT will be evaluated by postprocedural OCT (OCT-defined stent optimization will be assessed). In angiography-guided PCI arm, PCI for complex lesion will be performed without guidance of intravascular imaging, and routine use of high pressure postdilation with NC balloon will be also recommended. Primary endpoint will be evaluated during 12 months after PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Bypass graft lesion
- •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
研究组 & 干预措施
OCT-guided PCI
Patients will receive PCI under OCT-guidance.
干预措施: OCT-guided PCI (Device)
Angiography-guided PCI
Patients will receive PCI under Angiography-guidance.
干预措施: Angiography-guided PCI (Device)
结局指标
主要结局
Composite of major adverse cardiac events (MACEs)
时间窗: 1 year
Composite of major adverse cardiac events (MACEs) - for comparison between OCT-guided PCI vs. angiography-guided PCI
次要结局
- Any revascularization(1 year (except periprocedural MI - within 48 hours))
- Target lesion revascularization(1 year (except periprocedural MI - within 48 hours))
- Stroke(1 year (except periprocedural MI - within 48 hours))
- Stent optimization confirmed by OCT(1 year (except periprocedural MI - within 48 hours))
- Periprocedural myocardial infarction(1 year (except periprocedural MI - within 48 hours))
- Each component of MACE(1 year (except periprocedural MI - within 48 hours))
- Bleeding(1 year (except periprocedural MI - within 48 hours))
- Contrast-induced Nephropathy(1 year (except periprocedural MI - within 48 hours))