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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.
Full description
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.
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Inclusion criteria
Exclusion criteria
Angiographic exclusion criteria: any of the followings
Small vessel: mean reference size < 2.5 mm by quantitative coronary angiography
True bifurcation lesion with a large side branch (reference vessel diameter > 2.3mm) requiring a complex two-stent approach
Left main lesions
Ostial lesions within 3mm of the origin: right coronary artery, left anterior descending, or left circumflex artery
Impaired delivery of the Absorb bio- resorbable vascular scaffold is expected:
In-stent restenotic lesions
ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (with 12- 24 hour after symptoms onset)
Prior percutaneous coronary intervention within the target vessel during the last 12 months.
Prior percutaneous coronary intervention within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
Left ventricular ejection fraction (LVEF) < 30%
Hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
Persistent thrombocytopenia (platelet count <100,000/µl)
Any history of hemorrhagic stroke or intracranial hemorrhage, transient ischemic attack or ischemic stroke within the past 6 months
A known intolerance to a study drug (aspirin, clopidogrel or ticagrelor)
Patients requiring long-term oral anticoagulants or cilostazol
Any surgery requiring general anesthesia or discontinuation of aspirin and/or an Adenosine diphosphate(ADP) antagonist is planned within 12 months after the procedure.
A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alanine transaminase (ALT) or aspartate transaminase (AST) > 3 times upper limit of normal).
Life expectancy < 5 years for any non-cardiac or cardiac causes
Unwillingness or inability to comply with the procedures described in this protocol.
Patient's pregnant or breast-feeding or child-bearing potential.
Primary purpose
Allocation
Interventional model
Masking
84 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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