The objective of this trial is to compare clinical outcomes between imaging-guided and QCA-guided strategy in patients with native coronary artery disease undergoing BRS implantation.
The investigators hypothesized that intravascular imaging-guided BRS implantation is superior to QCA-guided BRS implantation with respect to target lesion failure in patients with native coronary artery disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
In the QCA-guided group, BRS size and length were chosen by both visual estimation and on-line QCA, and adjunct high-pressure dilation is routinely performed to achieve angiographic residual diameter stenosis less than 30% by QCA and absence of angiographically visible dissections.
In the imaging-guided group, imaging is used at any step of percutaneous coronary intervention(PCI) before, during, or after PCI. Final image examination after PCI is mandatory.
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: 1 year
Device success
Successful delivery and deployment of the study scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography (QCA).
Time frame: 1 hour after an index procedure
Procedural success
Achievement of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography with successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel myocardial infarction or repeat target lesion revascularization during the hospital stay.
Time frame: 24 hours after an index procedure
Death
cardiac, vascular, non-cardiovascular
Time frame: 1 year, and 5 years
Myocardial infarction
Time frame: 1 year, and 5 years
Scaffold thrombosis
Time frame: 1 year, and 5 years
Stroke
Time frame: 1 year, and 5 years
Target lesion revascularization
Time frame: 1 year, and 5 years
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Any revascularization
Time frame: 1 year, and 5 years
Target lesion failure (TLR)
cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization
Time frame: 1 year, and 5 years
A composite event
a composite event of cardiac death, target vessel myocardial infarction, stroke, or clinically significant bleeding(clinically significant bleeding by Bleeding Academic Research Consortium (BARC) type 2,3,4,5)
Time frame: 1 year, and 5 years
In-scaffold restenosis on coronary CT angiography
Time frame: 1 year, and 5 years