About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
ST-segment elevation MI at admission
Patients who underwent coronary artery bypass surgery or heart transplantation
Left ventricular ejection fraction <30%
Cardiogenic shock
Trial population
Between February 2020 and June 2027, a total of 3,000 patients who performe coronary angiography (± FFR) and have at least one coronary stenosis requiring PCI (as culprit) will be enrolled from 16 centers in South Korea.
Trial design
Case-only
Prospective
Treatments tested in this trial
percutaneous coronary intervention
Procedure/SurgeryIVUS-guided stent implantation
Treatment groups
Trial outcomes
Primary outcomes
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
nonculprit-related TVF
composite of cardiac death, MI, and clinically-driven TVR at 2 years
Secondary outcomes
each component of primary measures
each of cardiac death, non-fetal MI, ST and target vessel revascularization
all cause death
all cause death
repeat revascularization
repeat revascularization
stroke
stroke
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Asan Medical Center
Lead sponsor
Boston Scientific Corporation
Collaborator