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Clinical Trials in South Korea / NCT05807841
Recruiting Observational

Clinical Impact of Intravascular Ultrasound-Based Artificial Intelligence Technologies (INNOVATE-PCI)

NCT05807841 · tracked via the Priya Life Science South Korea tracker
Sponsor
Asan Medical Center
Phase
Observational
Started
2020-02-20
Last updated
2026-06-25

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

percutaneous coronary intervention

percutaneous coronary intervention: IVUS-guided stent implantation

Study summary

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).

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 19 years or older * Symptomatic angina patients with objective myocardial ischemia * Patients with at least one major epicardial coronary artery that requires stent implantation * Subject who signs with informed consent form Patient exclusion Criteria: * ST-segment elevation MI at admission * Patients who underwent coronary artery bypass surgery or heart transplantation * Left ventricular ejection fraction \<30% * Cardiogenic shock * Patients whose life expectancy \<2 years * Woman who are breastfeeding, pregnant or planning to become pregnant during study * Patients in whom anti-platelets or heparin is contraindicated Lesion exclusion Criteria: * Left main culprit lesion (angiographic diameter stenosis \>50%) * Thrombus-containing lesion * In-stent restenosis * Side branch lesion * Chronic total occlusion * Small vessel with reference diameter \<2.5mm * Coronary spasm despite administration of nitrate * Inability for imaging catheter to pass through tight stenosis, calcification, angulations * Poor image quality * Angiographically visible collateral vessels

Primary outcome measure(s)

  • culprit-related TVF — 2 years after stent implantation
    composite of cardiac death, myocardial infarction (MI), stent thrombosis, and clinically-driven target vessel revascularization (TVR) at 2 years after SynergyTM implantation
  • nonculprit-related TVF — 2 years after stent implantation
    composite of cardiac death, MI, and clinically-driven TVR at 2 years

Trial sites (16)

FacilityCityRegionStatus
Soon Chun Hyang University Hospital Bucheon Bucheon-si South Korea Recruiting
Gosin University Gospel Hospital Busan South Korea Recruiting
Inje University Pusan Paik Hospital Busan South Korea Recruiting
Gyeongsang National University Changwon Hospital Changwon South Korea Recruiting
Kangwon National University Hospital Chuncheon South Korea Recruiting
Keimyung University Dongsan Medical Center Daegu South Korea Recruiting
The Catholic university of korea, daejeon st. mary's hospital Daejeon South Korea Recruiting
Gangneung Asan Hospital Gangneung South Korea Recruiting
Jesushospital Jeonju South Korea Recruiting
Chungnam National University Sejong Hospital Sejong South Korea Recruiting
Seung-Whan Lee Seoul South Korea Recruiting
Kangbuk Samsung Medical Center Seoul South Korea Not Yet Recruiting
The Catholic university of korea, Eunpyeong st. mary's hospital Seoul South Korea Recruiting
Veterans Hospital Service Medical Center Seoul South Korea Recruiting
The Catholic University of Korea ST.VINCENT'S Hospital Suwon South Korea Recruiting
Ulsan University Hospital Ulsan South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05807841 on ClinicalTrials.gov ↗ ← All trials in South Korea