Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic

Status Completed

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

Clinical Trial Details

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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Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque — PREVENT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms