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NCT07741721
Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
Conditions: Myocardial Infarction (MI)
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1252
Sponsor: Chonnam National University Hospital
Location: Bucheon Sejong Hospital Bucheon-si
Summary
This prospective, multicenter, open-label, superiority trial will enroll patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. Following successful percutaneous coronary intervention (PCI) of the infarct-related artery (IRA), patients who meet the eligibility criteria will be randomized in a 1:1 ratio to either in-hospital staged complete revascularization with PCI of non-IRA lesions performed on a separate day during hospitalization, at least 48 hours after PCI of the IRA, or out-of-hospital staged complete revascularization with PCI of non-IRA lesions performed after discharge between 15 and 45 days of randomization. In both groups, non-IRA lesions with 50-69% stenosis will be evaluated using FFR.
Eligibility Criteria
Inclusion Criteria:
* Age ≥19 years
* ST-segment elevation myocardial infarction (STEMI): ST-segment elevation ≥ 0.1 mV in at least two contiguous leads, or New-onset left bundle branch block (LBBB)
* Primary PCI within 12 h after symptom development
* At least 1 non-infarct related artery (non-IRA) with diameter ≥ 2.5 mm and 50% stenosis by visual estimation
Exclusion Criteria:
* Cardiogenic shock at initial presentation or after infarct-related artery (IRA) treatment
* Thrombolysis in myocardial infarction flow at non-IRA ≤ 2
* Severe procedural complications during primary percutaneous coronary intervention that, in the judgement of the operator, preclude study enrollment
* Non-IRA lesion unsuitable for percutaneous coronary intervention (PCI) treatment that, in the judgement of the operator, preclude study enrollment
* Chronic total occlusion in a non-IRA
* History of anaphylaxis to contrast agent
* Pregnancy and lactation
* Life expectancy \< 1 year
* Severe valvular heart disease
* History of coronary artery bypass grafting (CABG) or planned CABG
* Fibrinolysis therapy prior to admission
* Severe asthma
Source: ClinicalTrials.gov (NCT07741721). StuddyBuddy aggregates publicly available trial information.