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

Recruiting now

Conditions studied: Coronary Artery Disease

In brief

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).

Key facts

Study ID

NCT05807841

Run by

Asan Medical Center

People needed

3000

Starts

2020-02-20

Expected to finish

2029-12-31

Last updated by the study team

2026-06-25

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Ulsan University Hospital — Ulsan, South Korea (enrolling)
• Gosin University Gospel Hospital — Busan, South Korea (enrolling)
• Inje University Pusan Paik Hospital — Busan, South Korea (enrolling)
• Gyeongsang National University Changwon Hospital — Changwon, South Korea (enrolling)
• Kangwon National University Hospital — Chuncheon, South Korea (enrolling)
• Keimyung University Dongsan Medical Center — Daegu, South Korea (enrolling)
• The Catholic university of korea, daejeon st. mary's hospital — Daejeon, South Korea (enrolling)
• Gangneung Asan Hospital — Gangneung, South Korea (enrolling)
• Jesushospital — Jeonju, South Korea (enrolling)
• Chungnam National University Sejong Hospital — Sejong, South Korea (enrolling)
• Seung-Whan Lee — Seoul, South Korea (enrolling)
• Soon Chun Hyang University Hospital Bucheon — Bucheon-si, South Korea (enrolling)
• The Catholic university of korea, Eunpyeong st. mary's hospital — Seoul, South Korea (enrolling)
• Veterans Hospital Service Medical Center — Seoul, South Korea (enrolling)
• The Catholic University of Korea ST.VINCENT'S Hospital — Suwon, South Korea (enrolling)
• Kangbuk Samsung Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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