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

Coronary Artery Disease Clinical Trial

Official title: a Multinational, Multicenter, Prospective, Open-label, Active-treatment-controlled Randomized Trial: Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque_PREVENT Trial

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. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Plaque, Atherosclerotic

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