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

Study Overview
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Brief Summary
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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).

Detailed Description
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The aim of the study is to evaluate the performances and prognostic impact of coronary angiography & IVUS-based algorithms for decision making and stent optimization in a multicenter, prospective cohort. Between January 2020 and June 2025, a total of 3,000 patients who performed coronary angiography (± FFR) and have at least one coronary stenosis requiring PCI (as culprit) will be enrolled from 15 centers in South Korea. In addition, the deferred lesions with visual estimated diameter stenosis of >30% will be evaluated as non-culprits. Brief study design is as depicted in the following figure. Supervised ML algorithms include: 1) angiography- and IVUS-based algorithms for predicting FFR, 2) IVUS-based algorithm for plaque characterization, 3) IVUS-based algorithm for predicting stent expansion, and 4) post-stenting IVUS-based algorithm for predicting stent failure. In the prospective cohort, the performance of each model will be assessed. This registry trial composed of the treated (culprit) and the deferred (nonculprit) coronary lesions has two primary objectives as follow; 1) Primary objectives in treated (culprit) lesions is to see the impact of the integrated ML model on the development of culprit-related 2-year target vessel failure (TVF). 2) Primary objectives in deferred (nonculprit) lesions is to see the impact of the integrated ML model on the development of nonculprit-related 2-year TVF.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: percutaneous coronary intervention|IVUS-guided stent implantation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| culprit-related TVF | composite of cardiac death, myocardial infarction (MI), stent thrombosis, and clinically-driven target vessel revascularization (TVR) at 2 years after SynergyTM implantation | 2 years after stent implantation | 
| nonculprit-related TVF | composite of cardiac death, MI, and clinically-driven TVR at 2 years | 2 years after stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| each component of primary measures | each of cardiac death, non-fetal MI, ST and target vessel revascularization | 2 years after stent implantation | 
| all cause death | all cause death | 2 years after stent implantation | 
| repeat revascularization | repeat revascularization | 2 years after stent implantation | 
| stroke | stroke | 2 years after stent implantation | 
| bleeding | bleeding | 2 years after stent implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous coronary intervention, artificial intelligence, machine learning, intravascular ultrasound, coronary angiography