Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

Completed · Phase 4

Conditions studied: Coronary Artery Disease, Plaque, Atherosclerotic

In brief

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.

Key facts

Study ID

NCT02316886

Run by

Seung-Jung Park

People needed

1608

Starts

2015-10-05

Expected to finish

2023-10-19

Last updated by the study team

2023-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged ≥18 years
• Patients with suspected or known Coronary artery disease who are undergoing invasive cardiac catheterization
• Patients with at least one significant stenosis (diameter stenosis >50%) with Fractional Flow Reserve (FFR) >0.80 and meeting two of the following criteria:
• MLA(minimal luminal area)<4mm2
• Plaque burden>70%
• Large lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy), defined as MaxLCBI4mm>315
• TCFA(thin-cap fibroatheroma) defined as fibrous cap thickness <65 μm and arc >90° on optical coherence tomography (OCT) or ≥10% confluent necrotic core with >30° abutting the lumen in three consecutive slices on Virtual-histology intravascular ultrasound (VH-IVUS)
• Eligible for percutaneous coronary intervention with Absorb Bioresorbable Vascular Scaffold or Everolimus Eluting Stent
• Reference vessel diameter 2.75-4.0
• Lesion length ≤ 40mm
• Willing and able to provide informed written consent

You may not qualify if…

• Patients for whom the preferred treatment is CABG(Coronary artery bypass grafting)
• Patients with stented lesions
• Patients with bypass graft lesions
• Patients with three or more target lesions
• Patients with two target lesions in the same coronary territory
• Patients with heavily calcified or angulated lesions
• Patients with bifurcation lesions requiring 2 stenting technique
• Patients with contraindications to or planned discontinuation of dual antiplatelet therapy within 1 year
• Patients with life expectancy <2 years
• Patients with planned cardiac or major noncardiac surgery
• Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study

Where it is running

• Columbia University Medical Center — New York, New York, United States
• Kyoto University Hospital — Kyoto, Japan
• Christchurch Hospital and Canterbury DHB, University of Otago — Christchurch, New Zealand
• Asan Medical Center — Seoul, Songpa-gu, South Korea
• Hallym University Sacred Heart Hospital — Anyang, South Korea
• Gangwon National Univ. Hospital — Chuncheon, South Korea
• Keimyung University Dongsan Medical Center — Daegu, South Korea
• Chungnam National University Hospital — Daejeon, South Korea
• The Catholic University of Korea, Daejeon ST. Mary's Hospital — Daejeon, South Korea
• Chonnam National University Hospital — Gwangju, South Korea
• Gachon University Gil Hospital — Incheon, South Korea
• ChonBuk National University Hospital — Jeonju, South Korea
• Samsung Medical Center — Seoul, South Korea
• Seoul National University hospital — Seoul, South Korea
• The Catholic University of Korea Seoul St. Mary's Hospital — Seoul, South Korea
• Bundang Cha Medical Center — Sŏngnam, South Korea
• Seoul National University Bundang hospital — Sŏngnam, South Korea
• National Taiwan University Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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