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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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The primary aim of this study is to compare the clinical efficacy and safety of OCT-guided(optical coherence tomography (OCT)-guided) and IVUS-guided(Intravascular ultrasound (IVUS)-guided) strategies in patients undergoing Percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) or drug-coated balloons (only for in-stent restenosis) for significant obstructive Coronary artery disease (CAD).
The investigators hypothesize that OCT-guided PCI is non-inferior to IVUS-guided PCI with respect to primary end point of target-vessel failure (cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-vessel revascularization [TVR]) at 1 year after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT-guided | Experimental |
| |
| IVUS-guided | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI | Procedure | Percutaneous Coronary Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of target vessel failure | A composite of cardiac death, target-vessel MI or ischemia-driven TVR) at 1 year after randomization. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cardiac Death | 1, and 5 years | |
| Rate of target vessel myocardial infarction | 1, and 5 years | |
| Rate of ischemia-driven target vessel revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duk-woo Park, MD | Professor, Division of Cardiology, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Medical Center | Daegu | South Korea | ||||
| Konyang University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41999374 | Derived | Wee SB, Kang DY, Ahn JM, Park HS, An SY, Seo KW, Lee SH, Yun SC, Baek S, Hur SH, Cho YK, Lee CH, Hong SJ, Lim S, Kim SW, Won H, Hong YJ, Yoon YH, Yoon YW, Bae JH, Park SJ, Park DW; OCTIVUS Investigators. Percutaneous Coronary Intervention Guided by Optical Coherence Tomography or Intravascular Ultrasound for True Bifurcation Lesions. JACC Asia. 2026 Mar 31:S2772-3747(26)00118-3. doi: 10.1016/j.jacasi.2026.02.019. Online ahead of print. | |
| 40272346 |
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| 1, and 5 years |
| Rate of death | cardiac, vascular, non-cardiovascular death | 1, and 5 years |
| Rate of myocardial infarction | periprocedural or spontaneous, Q-wave or non-Q-wave. | 1, and 5 years |
| Rate of stent thrombosis | Stent thrombosis is defined according to according to the definite or probable criteria of the Academic Research Consortium. | 1, and 5 years |
| Rate of stroke | Stroke is defined as focal loss of neurologic function caused by an ischemic or hemorrhagic event, with residual symptoms lasting at least 24 hours or leading to death. | 1, and 5 years |
| Rate of repeat revascularization | Any, target-lesion or non-target-lesion, target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven. | 1, and 5 years |
| Rate of any hospitalization | Cardiac or non-cardiac causes. | 1, and 5 years |
| Rate of bleeding events | Life-threatening or disabling, major bleeding, or minor. Bleeding events are assessed according to the Bleeding Academic Research Consortium (BARC) criteria. | 1, and 5 years |
| Rate of target-lesion failure | Cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization | 1, and 5 years |
| Rate of contrast-induced acute kidney injury | Contrast-induced nephropathy is defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dl within 72 hours after PCI. | 3 days |
| Rate of procedural complications requiring active intervention that were related to PCI or intracoronary imaging devices | Procedural complications (e.g., angiographic dissection of at least type B, coronary perforation, vasospasm, thrombus formation, air embolization, slow flow or no reflow, distal embolization, acute closure, ventricular arrhythmia, cardiac tamponade, or cardiogenic shock) requiring active interventions (prolonged balloon inflations, additional stenting required, thrombus aspiration, pericardiocentesis, cardioversion, or use of mechanical circulatory support devices), which are related to PCI procedures or intravascular imaging evaluation. | 1 day |
| Rate of angiographic or imaging-based device success | Patient- or lesion-level analysis. Angiographic device success is defined as successful PCI at the intended target-lesion with final in-stent residual stenosis of less than 30% by quantitative coronary angiography (QCA). Imaging-based device success is defined as successful PCI at the intended target-lesion, which fulfills the optimal criterial for stent implantation by IVUS or OCT. | 1 day |
| Daejeon |
| South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Pusan National University Hospital | Pusan | South Korea |
| Asan Medical Hospital | Seoul | South Korea |
| Chung-Ang university hospital | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Kyung hee university hospital | Seoul | South Korea |
| Derived |
| Kim H, Kang DY, Ahn JM, Kim HJ, Hur SH, Cho YK, Lee CH, Hong SJ, Kim SW, Won H, Oh JH, Hong YJ, Yoon YH, Park SJ, Park DW; OCTIVUS Investigators. Proportion and Clinical Impact of Stent Optimization During Imaging-Guided Percutaneous Coronary Intervention: The OCTIVUS Trial. JACC Cardiovasc Interv. 2025 May 12;18(9):1089-1099. doi: 10.1016/j.jcin.2025.01.436. Epub 2025 Apr 23. |
| 37879490 | Derived | Kang DY, Ahn JM, Yun SC, Hur SH, Cho YK, Lee CH, Hong SJ, Lim S, Kim SW, Won H, Oh JH, Choe JC, Hong YJ, Yoon YH, Kim H, Choi Y, Lee J, Yoon YW, Kim SJ, Bae JH, Park SJ, Park DW; OCTIVUS Investigators. Guiding Intervention for Complex Coronary Lesions by Optical Coherence Tomography or Intravascular Ultrasound. J Am Coll Cardiol. 2024 Jan 23;83(3):401-413. doi: 10.1016/j.jacc.2023.10.017. Epub 2023 Oct 23. |
| 37634092 | Derived | Kang DY, Ahn JM, Yun SC, Hur SH, Cho YK, Lee CH, Hong SJ, Lim S, Kim SW, Won H, Oh JH, Choe JC, Hong YJ, Yoon YH, Kim H, Choi Y, Lee J, Yoon YW, Kim SJ, Bae JH, Park DW, Park SJ; OCTIVUS Investigators. Optical Coherence Tomography-Guided or Intravascular Ultrasound-Guided Percutaneous Coronary Intervention: The OCTIVUS Randomized Clinical Trial. Circulation. 2023 Oct 17;148(16):1195-1206. doi: 10.1161/CIRCULATIONAHA.123.066429. Epub 2023 Aug 27. |
| 32871327 | Derived | Kang DY, Ahn JM, Park H, Lee PH, Kang SJ, Lee SW, Kim YH, Park SW, Kim SW, Hur SH, Cho YK, Lee CH, Hong SJ, Hong YJ, Yoon YW, Kim SJ, Bae JH, Oh JH, Park DW, Park SJ. Comparison of optical coherence tomography-guided versus intravascular ultrasound-guided percutaneous coronary intervention: Rationale and design of a randomized, controlled OCTIVUS trial. Am Heart J. 2020 Oct;228:72-80. doi: 10.1016/j.ahj.2020.08.003. Epub 2020 Aug 8. |