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Clinical Trial Summary

The primary aim of the trial is to determine whether preventive PCI with bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) plus optimal medical therapy (OMT) on functionally insignificant (FFR > 0.80) vulnerable coronary plaque, as determined by intracoronary imaging, would result in a significant reduction of the primary composite outcome of death from cardiac causes, target-vessel myocardial infarction (MI), target-vessel revascularization (TVR), and hospitalization for unstable or progressive angina at 2 years, when compared with OMT alone.


Clinical Trial Description

Sub-analysis for each imaging test will be performed as below; - NIRS(Near-infrared spectroscopy) - OCT(Optical coherence tomography) - VH-IVUS(IVUS-derived virtual histology) - IVUS(Intravascular ultrasonography) Extended follow-up: Considering the nature of functionally insignificant coronary stenosis with vulnerable plaque, most subjects are watched for extended follow-up after the planned 2-year follow-up time point. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02316886
Study type Interventional
Source Asan Medical Center
Contact
Status Completed
Phase Phase 4
Start date October 5, 2015
Completion date October 19, 2023

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