Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)

Launched by YONSEI UNIVERSITY · Aug 7, 2018

Keywords

ClinConnect Summary

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 postd...

Gender

ALL

Eligibility criteria

• • 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 to understand or read the informed content