Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Ran… (NCT03625908) | Clinical Trial Compass
CompletedNot Applicable
Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
South Korea1,604 participantsStarted 2019-01-09
Plain-language summary
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.
Who can participate
Age range19 Years – 85 Years
SexALL
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Inclusion criteria
* 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
Exclusion criteria
* 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 t…