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

Recruitingn/aAges 19 Years - anyAllAsan Medical Center
NCT05807841 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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
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What it tests

  • percutaneous coronary intervention
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Where

16 sites
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

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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