Optical CoherenCe tomography-gUided coronary intervention in Patients with complex lesIons: a randomized controlled trial (OCCUPI trial)
- Conditions
- Diseases of the circulatory system
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1604
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
- 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MACE (major adverse cardiac event)
- Secondary Outcome Measures
Name Time Method Each component of MACE(major adverse cardiac event);Target lesion revascularization;Periprocedural myocardial infarction;Bleeding;Any revascularization;Stroke;Stent thrombosis confirmed by OCT;Contrast-induced Nephropathy