The present study is a prospective randomized clinical trial aimed to compare the therapeutic strategy of angiography-guided versus concurrent OCT/FFR-guided intervention in patients with coronary artery disease.
Most previous clinical trials have assessed various interventional strategies guided by intravascular imaging (intravascular imaging-guided PCI), fractional flow reserve (FFR-guided PCI), or conventional angiography (angiography-guided PCI) to compare differences in treatment outcomes. Until now, it remains unclear whether optimizing procedures based on both intravascular imaging and fractional flow reserve indices would lead to improved treatment outcomes compared to PCI guided solely by conventional angiography. Moreover, there are no studies comparing a treatment strategy that combines optical coherence tomography (OCT) and FFR to angiography-guided procedures. Hence, this study aims to compare the clinical effectiveness and therapeutic impact of concurrent guidance using FFR and OCT in patients undergoing coronary artery stent implantation, as compared to procedures guided solely by conventional angiography.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
700
The assessment of pre-procedural lesions and optimization status of implanted stents will involve both intracoronary imaging and physiological indices.
The assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography
Korea University Guro Hospital
Seoul, South Korea
RECRUITINGRate of target vessel failure (TVF)
a composite endpoint of cardiac death, target vessel-related non-fatal myocardial infarction, clinically driven-target vessel revascularization
Time frame: 1-year
Rate of all-cause mortality
cardiac and non-cardiac death
Time frame: 1-year
Rate of any myocardial infarction (MI)
myocardial infarction due to target vessel and non-target vessel failure
Time frame: 1-year
Rate of clinically-driven target vessel revascularization (TVR)
clinically-driven target vessel revascularization
Time frame: 1-year
Rate of any revascularization
clinically-driven target lesion and non-target lesion revascularization
Time frame: 1-year
Rate of stent thrombosis (acute, subacute, late, very late)
stent thrombosis based on presenting time after the index procedure
Time frame: 1-year
Rate of BARC-defined bleeding
clinically-relevant bleeding event based on BARC classification
Time frame: 1-year
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