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Recruiting 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07741721). StuddyBuddy aggregates publicly available trial information.