RecruitingNCT05807841

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

Influence of Novel Intravascular Ultrasound-Based Artificial Intelligence Technologies on Event Reduction Following Percutaneous Coronary Intervention (INNOVATE-PCI)

Sponsor

Asan Medical Center

Enrollment

3,000 participants

Start Date

Feb 20, 2020

Study Type

OBSERVATIONAL

Conditions

Coronary Artery Disease

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

Min Age: 19 Years

Inclusion Criteria4

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

Exclusion Criteria17

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
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

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Interventions

PROCEDUREpercutaneous coronary intervention

IVUS-guided stent implantation

Locations(16)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Gosin University Gospel Hospital

Busan, South Korea

Inje University Pusan Paik Hospital

Busan, South Korea

Gyeongsang National University Changwon Hospital

Changwon, South Korea

Kangwon National University Hospital

Chuncheon, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

The Catholic university of korea, daejeon st. mary's hospital

Daejeon, South Korea

Gangneung Asan Hospital

Gangneung, South Korea

Jesushospital

Jeonju, South Korea

Chungnam National University Sejong Hospital

Sejong, South Korea

Seung-Whan Lee

Seoul, South Korea

Kangbuk Samsung Medical Center

Seoul, South Korea

The Catholic university of korea, Eunpyeong st. mary's hospital

Seoul, South Korea

Veterans Hospital Service Medical Center

Seoul, South Korea

The Catholic University of Korea ST.VINCENT'S Hospital

Suwon, South Korea

Ulsan University Hospital

Ulsan, South Korea

View Full Details on ClinicalTrials.gov

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NCT05807841

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