None listed
Conditions
Interventions
Drug, Medical Device, Procedure/Surgery : Coronary intervention with Bioresorbable Vascular Scaffold or Everolimus Eluting stent (EES) +Optimal Medical Treatment vs optimal medical treatment
*Optimal
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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)70% Lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy) (defined as maxLCBI4mm>315) TCFA(thin-cap fibroatheroma) defined by OCT(fibrous cap thickness90°) 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target vessel failure from cardiac death, target vessel related MI, ischemia-driven target vessel revascularization, or unplanned hospitalization for angina | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactJung-hee Ham
Asan Medical Center
Outcome results
None listed