This study is a prospective, randomized, multi-center, open label trial to compare the clinical outcomes and effectiveness of Intravascular ultrasound (IVUS) versus Fractional Flow Reserve (FFR) guided Percutaneous coronary intervention (PCI) with intermediate coronary artery lesion.
This trial is a prospective, randomized, open label, two arm designed multi-center trial. When diagnostic coronary angiogram shows that the target lesion is intermediate stenosis, IVUS and/or FFR will be performed in order to decide PCI or defer by 1:1 randomization. The patients would be followed up to 2 years clinically.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,400
minimal lumen area on Intravascular ultrasound
Fractional flow reserve measured by pressure wire
Keimyung university Dongsan medical center
Daegu, South Korea
Inje University
Ilsan, South Korea
Korea University Guro Hospital
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)
Time frame: 1 year
Cardiac death
Time frame: 1 and 2 years
Myocardial infarction (MI)
Time frame: 1 and 2 years
Composite of cardiac death or myocardial infarction
Time frame: 1 and 2 years
Target vessel revascularization (ischemia- and clinically-driven)
Time frame: 1 and 2 years
Target lesion revascularization (ischemia- and clinically-driven)
Time frame: 1 and 2 years
Stent thrombosis (Academic Research Consortium criteria)
Time frame: 1 and 2 years
In-stent and in-segment late loss on angiographic follow-up
Time frame: 1 year
In-stent and in-segment restenosis rate
Time frame: 1 year
Incidence and angiographic pattern of restenosis
Time frame: 1 year
Canadian Cardiovascular Society Classification status
Time frame: 1 and 2 years
The number of anti-angina medication
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Seoul national university hospital
Seoul, South Korea
Yensei University Gangnam Severance Hospital
Seoul, South Korea
Ajou University Medical Center
Suwon, South Korea
Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital
Wŏnju, South Korea
Time frame: 1 and 2 years
Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group
Time frame: Baseline (day 0)
Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)
Time frame: 2 years