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โ† Trials
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Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)

RecruitingNAAges 19 Years - anyAllChonnam National University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ19 years * ST-segment elevation myocardial infarction (STEMI): ST-segment elevation โ‰ฅ 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 โ‰ฅ 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 โ‰ค 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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What it tests

  • In-hospital staged complete revascularization
  • Out-of-hospital staged complete revascularization
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Where

30 sites
Bucheon Sejong Hospital
Bucheon-si, South Korea
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Samsung Changwon Medical Center
Changwon, South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea

โ€ฆand 22 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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