Randomized Controlled Trial of Intravascular Ultrasound Versus Fractional Flow Reserve for Non-infarct Related Artery Lesions in Patients with Multivessel Disease and Acute STEMIIntravascular Ultrasound Versus Fractional Flow Reserve for Non-infarct Related Artery Lesions in Patients with MultivEssel Disease and Acute STEMI(FRAME-AMI 2 Trial)

Samsung Medical Center0 个研究点目标入组 1,400 人开始时间: 待定最近更新: 2023年4月4日

试验速览

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•?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 block1
•?Successful primary percutaneous coronary intervention (PCI) for IRA in <12 h after the onset of symptoms
•?Multivessel disease (at least one stenosis of >50% in a non-IRA =2.25 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.

•?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.

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