RecruitingNCT05807841

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

Sponsor: Asan Medical Center

Trial Details

ConditionCoronary Artery Disease
Interventionpercutaneous coronary intervention
StatusRecruiting
Participants3,000
Est. Completion31 Dec 2028
Last Updated25 June 2026

Primary Outcome

culprit-related TVF; nonculprit-related TVF

Eligibility Criteria

Inclusion Criteria

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

Trial Sites

Countries

South Korea
View Registry Entry

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