Clinical Impact of Intravascular Ultrasound-Based Artificial Intelligence Technologies (INNOVATE-PCI)
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT05807841
- Lead Sponsor
- Asan Medical Center
- Brief 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method nonculprit-related TVF 2 years after stent implantation composite of cardiac death, MI, and clinically-driven TVR at 2 years
culprit-related TVF 2 years after stent implantation composite of cardiac death, myocardial infarction (MI), stent thrombosis, and clinically-driven target vessel revascularization (TVR) at 2 years after SynergyTM implantation
- Secondary Outcome Measures
Name Time Method repeat revascularization 2 years after stent implantation repeat revascularization
each component of primary measures 2 years after stent implantation each of cardiac death, non-fetal MI, ST and target vessel revascularization
all cause death 2 years after stent implantation all cause death
stroke 2 years after stent implantation stroke
bleeding 2 years after stent implantation bleeding
Trial Locations
- Locations (16)
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Gosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Inje University Pusan Paik Hospital
🇰🇷Busan, Korea, Republic of
Gyeongsang National University Changwon Hospital
🇰🇷Changwon, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
The Catholic university of korea, daejeon st. mary's hospital
🇰🇷Daejeon, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Jesushospital
🇰🇷Jeonju, Korea, Republic of
Chungnam National University Sejong Hospital
🇰🇷Sejong, Korea, Republic of
Seung-Whan Lee
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic university of korea, Eunpyeong st. mary's hospital
🇰🇷Seoul, Korea, Republic of
Veterans Hospital Service Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea ST.VINCENT'S Hospital
🇰🇷Suwon, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of