The Preventive Coronary Intervention on Stenosis With Functionally Insignificant Vulnerable Plaque

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0002893

Lead Sponsor: Asan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1600

Inclusion Criteria

Age 19 years or older
Symptomatic or asymptomatic coronary artery disease patients
Patients having at least one significant stenosis (diameter stenosis > 50%) with FFR >0.80 and meeting two of the following:

MLA(minimal luminal area)<4mm2
plaque burden>70%
Lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy) (defined as maxLCBI4mm>315)
TCFA(thin-cap fibroatheroma) defined by OCT(fibrous cap thickness<65µm and arc>90°) or VH-IVUS=10% confluent NC with>30° abutting to the lumen in 3 consecutive slices)

2 target vulnerable lesions
Eligible for percutaneous coronary intervention with Absorb Bioresorbable Vascular Scaffold or Everolimus Eluting Stent
Willing and able to provide informed written consent
Reference vessel diameter 2.75-4.0
Lesion length = 40

Exclusion Criteria

Patients in whom the preferred treatment is CABG(Coronary artery bypass grafting)
Stented lesion
Bypass graft lesion
The patients who have more than or equal to 3 target lesions
2 target lesions in the same coronary territory
Heavily calcified or angulated lesion
Bifurcation lesion requiring 2 stenting technique
Contraindication to or planned discontinuation of dual antiplatelet therapy within 1 year
Life expectancy less than 2 years
Planned cardiac surgery or planned major non cardiac surgery
Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target vessel failure from cardiac death, target vessel related MI, ischemia-driven target vessel revascularization, or unplanned hospitalization for angina

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac event defined as cardiovascular death, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable angina;Target lesion failure, defined as a composite of cardiovascular death, target lesion related myocardial infarction, or target lesion revascularization;Death from any causes;The composite of death, myocardial infarction, and any repeat revascularization;Cardiac death;Target vessel-related myocardial infarction;Target vessel revascularization;Cardiac death and combinations of cardiac death with other components of MACE at each time point;Non-urgent revascularization procedures;Unplanned hospitalization for angina;CCS Classification : Canadian Cardiovascular Society grading of angina pectoris;Number of anti-anginal medication at each point in time;Rate of non-urgent (repeat) revascularization at each point in time