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Clinical Impact of Intravascular Ultrasound-Based Artificial Intelligence Technologies (INNOVATE-PCI)
RECRUITINGSponsored by Asan Medical Center
Actively Recruiting
SponsorAsan Medical Center
Started2020-02-20
Est. completion2028-06-30
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05807841
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
Age: 19 Years+Healthy volunteers accepted
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
Conditions2
Coronary Artery DiseaseHeart Disease
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
SponsorAsan Medical Center
Started2020-02-20
Est. completion2028-06-30
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05807841