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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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This study is a prospective, multicenter study in the real practice to validate the diagnostic performances and clinical impact of coronary angiography & intravascular ultrasound (IVUS)-based models developed by machine learning (ML).
The aim of the study is to evaluate the performances and prognostic impact of coronary angiography & IVUS-based algorithms for decision making and stent optimization in a multicenter, prospective cohort. Between January 2020 and June 2027, a total of 3,000 patients who performed coronary angiography (± FFR) and have at least one coronary stenosis requiring PCI (as culprit) will be enrolled from 16 centers in South Korea. In addition, the deferred lesions with visual estimated diameter stenosis of >30% will be evaluated as non-culprits. Brief study design is as depicted in the following figure.
Supervised ML algorithms include: 1) angiography- and IVUS-based algorithms for predicting FFR, 2) IVUS-based algorithm for plaque characterization, 3) IVUS-based algorithm for predicting stent expansion, and 4) post-stenting IVUS-based algorithm for predicting stent failure. In the prospective cohort, the performance of each model will be assessed. This registry trial composed of the treated (culprit) and the deferred (nonculprit) coronary lesions has two primary objectives as follow; 1) Primary objectives in treated (culprit) lesions is to see the impact of the integrated ML model on the development of culprit-related 2-year target vessel failure (TVF). 2) Primary objectives in deferred (nonculprit) lesions is to see the impact of the integrated ML model on the development of nonculprit-related 2-year TVF.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous coronary intervention | Procedure | IVUS-guided stent implantation |
| Measure | Description | Time Frame |
|---|---|---|
| culprit-related TVF | composite of cardiac death, myocardial infarction (MI), stent thrombosis, and clinically-driven target vessel revascularization (TVR) at 2 years after SynergyTM implantation | 2 years after stent implantation |
| nonculprit-related TVF | composite of cardiac death, MI, and clinically-driven TVR at 2 years | 2 years after stent implantation |
| Measure | Description | Time Frame |
|---|---|---|
| each component of primary measures | each of cardiac death, non-fetal MI, ST and target vessel revascularization | 2 years after stent implantation |
| all cause death | all cause death |
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Inclusion Criteria:
Patient exclusion Criteria:
Lesion exclusion Criteria:
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Between February 2020 and June 2027, a total of 3,000 patients who performe coronary angiography (± FFR) and have at least one coronary stenosis requiring PCI (as culprit) will be enrolled from 16 centers in South Korea.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung-Whan Lee, MD | Contact | 82-10-7398-9897 | seungwlee@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Seung-Whan Lee, MD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital Bucheon | Recruiting | Bucheon-si | South Korea |
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| 2 years after stent implantation |
| repeat revascularization | repeat revascularization | 2 years after stent implantation |
| stroke | stroke | 2 years after stent implantation |
| bleeding | bleeding | 2 years after stent implantation |
| Gosin University Gospel Hospital | Recruiting | Busan | South Korea |
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| Inje University Pusan Paik Hospital | Recruiting | Busan | South Korea |
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| Gyeongsang National University Changwon Hospital | Recruiting | Changwon | South Korea |
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| Kangwon National University Hospital | Recruiting | Chuncheon | South Korea |
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| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
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| The Catholic university of korea, daejeon st. mary's hospital | Recruiting | Daejeon | South Korea |
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| Gangneung Asan Hospital | Recruiting | Gangneung | South Korea |
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| Jesushospital | Recruiting | Jeonju | South Korea |
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| Chungnam National University Sejong Hospital | Recruiting | Sejong | South Korea |
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| Seung-Whan Lee | Recruiting | Seoul | 05505 | South Korea |
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| Kangbuk Samsung Medical Center | Not yet recruiting | Seoul | South Korea |
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| The Catholic university of korea, Eunpyeong st. mary's hospital | Recruiting | Seoul | South Korea |
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| Veterans Hospital Service Medical Center | Recruiting | Seoul | South Korea |
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| The Catholic University of Korea ST.VINCENT'S Hospital | Recruiting | Suwon | South Korea |
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| Ulsan University Hospital | Recruiting | Ulsan | South Korea |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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