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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: OCT-guided PCI
* Device: Angiography-guided PCI


Participation Criteria
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Eligibility Criteria
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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 to understand or read the informed content

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Patients will be assigned by use of OCT-guidance or angiography-guidance for stent implantation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OCT-guided PCI<br>Patients will receive PCI under OCT-guidance. | Device: OCT-guided PCI<br>* Patients will receive PCI under OCT-guidance. Predefined criteria for optimization of PCI under OCT-guidance will be recommended to achieve as far as possible.<br>|
| Active Comparator: Angiography-guided PCI<br>Patients will receive PCI under Angiography-guidance. | Device: Angiography-guided PCI<br>* Stent optimization using high-pressure non-compliance balloon will be highly recommend. Balloon size would not be less than the stent diameter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of major adverse cardiac events (MACEs) | Composite of major adverse cardiac events (MACEs) - for comparison between OCT-guided PCI vs. angiography-guided PCI | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Each component of MACE | MACE = composite of cardiac death, myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization | 1 year (except periprocedural MI - within 48 hours) | 
| Any revascularization |  | 1 year (except periprocedural MI - within 48 hours) | 
| Target lesion revascularization |  | 1 year (except periprocedural MI - within 48 hours) | 
| Periprocedural myocardial infarction | Periprocedural MI - PCI-related myocardial infarction (>5x or >10x ULN) | 1 year (except periprocedural MI - within 48 hours) | 
| Bleeding | Bleeding defined by BARC and TIMI criteria | 1 year (except periprocedural MI - within 48 hours) | 
| Stroke |  | 1 year (except periprocedural MI - within 48 hours) | 
| Stent optimization confirmed by OCT | The attainment(optimal or acceptable) of criteria regarding stent expansion is strongly recommended. As for the other criteria, further procedures could be decided by the operators' decisions considering the situations. Stent expansion Optimal - meeting of all criteria Acceptable - meeting of any one criteria 1) MSA≥80% of mean reference lumen area 2) ≥100% of distal reference lumen area 3) MSA of >4.5 mm2 in non-left main lesion Stent apposition Optimal - acute stent malposition<200μm Acceptable - acute stent malposition<400μm Edge dissection(Definition of major edge dissection; any one of the followings) 1) ≥60°of the circumference of the vessel at site of dissection 2) Length of dissection ≥3mm 3) Deeper vessel injury(intramural hematoma or penetration to the media or adventitia) | 1 year (except periprocedural MI - within 48 hours) | 
| Contrast-induced Nephropathy |  | 1 year (except periprocedural MI - within 48 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Optical coherence tomography, antiplatelet therapy