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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT-guided PCI | Active Comparator | Patients will receive PCI under OCT-guidance. |
|
| Angiography-guided PCI | Active Comparator | Patients will receive PCI under Angiography-guidance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT-guided PCI | Device | 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. |
| 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 |
| 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 |
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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):
Patients who provide signed informed consent
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41999373 | Derived | Roh JW, Lee OH, Heo SJ, Im E, Cho DK, Lee SJ, Lee JY, Kim JW, Kim SM, Hur SH, Heo JH, Jang JY, Koh JS, Won H, Lee JW, Hong SJ, Kim DK, Choe JC, Lee JB, Yang TH, Lee JH, Hong YJ, Ahn JH, Hong SJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim Y, Kim BK; OCCUPI Investigators. OCT-Guided PCI According to Lesion Length and Vessel Diameter: Post Hoc Analysis of OCCUPI Trial. JACC Asia. 2026 Apr 15:S2772-3747(26)00158-4. doi: 10.1016/j.jacasi.2026.02.023. Online ahead of print. | |
| 41489717 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Patients will be assigned by use of OCT-guidance or angiography-guidance for stent implantation.
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| Angiography-guided PCI | Device | Stent optimization using high-pressure non-compliance balloon will be highly recommend. Balloon size would not be less than the stent diameter. |
|
| 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.
| 1 year (except periprocedural MI - within 48 hours) |
| Contrast-induced Nephropathy | 1 year (except periprocedural MI - within 48 hours) |
| Derived |
| Lee YJ, Kim Y, Lee OH, Cho DK, Lee SH, Lee SJ, Lee JY, Kim JW, Kim SM, Hur SH, Heo JH, Jang JY, Koh JS, Won H, Lee JW, Hong SJ, Kim DK, Choe JC, Lee JB, Yang TH, Lee JH, Hong YJ, Ahn JH, Hong SJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim BK, Occupi Investigators OBOT. Optical coherence tomography-guided percutaneous coronary intervention in acute coronary syndrome patients with complex lesions: a subgroup analysis of the randomised OCCUPI Trial. EuroIntervention. 2025 Nov 3;21(21):e1269-e1280. doi: 10.4244/EIJ-D-25-00478. |
| 39236729 | Derived | Hong SJ, Lee SJ, Lee SH, Lee JY, Cho DK, Kim JW, Kim SM, Hur SH, Heo JH, Jang JY, Koh JS, Won H, Lee JW, Hong SJ, Kim DK, Choe JC, Lee JB, Kim SJ, Yang TH, Lee JH, Hong YJ, Ahn JH, Lee YJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim BK; OCCUPI investigators. Optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention for patients with complex lesions (OCCUPI): an investigator-initiated, multicentre, randomised, open-label, superiority trial in South Korea. Lancet. 2024 Sep 14;404(10457):1029-1039. doi: 10.1016/S0140-6736(24)01454-5. Epub 2024 Sep 2. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |