The purpose of this study is to compare clinical outcomes between quantitative coronary angiography -guided and Intravascular ultrasound -guided strategy in patients with significant coronary artery disease undergoing sirolimus-eluting Orsiro/Orsiro mission stent implantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,528
In the quantitative coronary angiography-guided group, sirolimus-eluting Orsiro/Orsiro mission stent size and length is chosen to cover the entire length of the culprit lesions according to quantitative coronary angiography measurements. Selection of the sirolimus-eluting Orsiro/Orsiro mission stent size should be guided by both quantitative coronary angiography measurement and visual estimate, and is recommended to be based on distal reference vessel diameter by quantitative coronary angiography (distal reference vessel diameter by quantitative coronary angiography plus \~10% of distal reference vessel diameter).
In the intravascular ultrasound -guided group, sirolimus-eluting Orsiro/Orsiro mission stent size and length is selected by intravascular ultrasound measurements.
Korea University Anam Hospital
Anam, South Korea
Hallym University Medical Center
Gyeonggi-do, South Korea
National Health Insurance Service Ilsan Hospital
Ilsan, South Korea
Asan Medical Center
Seoul, South Korea
Target lesion failure
the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 12 months after the index procedure.
Time frame: 12 months
Procedural success
Achievement of final stent residual stenosis of less than 30% by QCA with successful deployment of at least one stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (24 hour after an index procedure).
Time frame: 24 hours
Death (cardiac, vascular, non-cardiovascular)
Time frame: 12 months
Myocardial infarction
Time frame: 12 months
Stent thrombosis (definite/probable)
Time frame: 12 months
Stroke
Time frame: 12 months
Target lesion revascularization
Time frame: 12 months
Any revascularization
Time frame: 12 months
Economic analysis
cost-effectiveness of QCA- versus IVUS-guided DES implantation
Time frame: 12 months
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Gangnam Severance Christian Hospital
Seoul, South Korea
Kangbuk Samsung Medical Center
Seoul, South Korea