None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : After primary PCI for IRA of patients with AMI and multivessel disease (at least >50% stenosis in non-IRA by visual estimation) who are eligible for enrollment with
MLA = 3mm2 or 3mm2 70% in IVUS-guided strategy group), the revascularization procedure will be performed or not.
If any violation of the protocols (for example, PCI is performed despite FFR >0.80 in
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Subject must be at least 19 years of age ? Acute ST-segment elevation myocardial infarction (STEMI) *STEMI: ST-segment elevation =0.1 mV in =2 contiguous leads or documented newly developed left bundle-branch block ? Acute non-ST-segment elevation myocardial infarction (NSTEMI) *NSTEMI: NSTEMI is defined as a combination of criteria with mandated elevation of a cardiac biomarker, preferably high-sensitive cardiac troponin with at least one value above 99th percentile of the upper reference limit and at least one of the following: 1) Symptoms of ischemia. 2) New or presumed new significant ST-T wave changes 3) Development of pathological Q waves on electrocardiography. 4) Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality. 5) Intracoronary thrombus detected on angiography. ? Primary percutaneous coronary intervention (PCI) in 50% in a non-IRA = 2.0 mm by visual estimation) ? Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Exclusion criteria
Exclusion criteria: ? Non-IRA stenosis not amenable for PCI treatment by operators’ decision ? Cardiogenic shock (Killip class IV) already at presentation or the completion of IRA PCI ? Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus ? Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock) ? Pregnancy or breast feeding ? Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator’s medical judgment) ? Other primary valvular disease with severe degree: severe mitral regurgitation, mitral stenosis, severe aortic regurgitation, or aortic stenosis ? Unwillingness or inability to comply with the procedures described in this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-Oriented Composite Outcome (a composite of death, MI, or repeat revascularization) after PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| all-cause and cardiac death, any myocardial infarction with or without periprocedural myocardial infarction, any revascularization, IRA repeat revascularization, non-IRA repeat revascularization, definite stent thrombosis and stroke | — |
Countries
Korea, Republic of
Contacts
Public ContactSuyoun Shin
Samsung Medical Center
Outcome results
None listed