IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center
About this trial
The aim of the study is to compare clinical outcomes between intravascular ultrasound (IVUS)-guided treatment decision versus fractional flow reserve (FFR)-guided treatment decision for non-infarct related artery stenosis in patients with acute myocardial infarction (AMI) and multivessel disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must be at least 19 years of age
Acute ST-segment elevation myocardial infarction (STEMI)
Acute non-ST-segment elevation myocardial infarction (NSTEMI)
Symptoms of ischemia.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
IVUS-guided PCI group
Diagnostic testIn IVUS-guided PCI group, the current trial evaluates clinical outcome following IVUS-guided treatment decision for revascularization of non-IRA stenosis.
FFR-guided PCI group
Diagnostic testIn FFR-guided PCI group, FFR measurement for non-IRA stenosis (\>50% visual estimation) will be performed by continuous infusion of adenosine (140\~180 ug/kg/min) or intracoronary nicorandil (2 mg bolus) injection. The FFR ≤0.80 will be targeted for PCI. In case of non-IRA stenosis \>90%, we will judge FFR value of ≤0.80.
Treatment groups
1,400 Participants
are divided into 2 treatment groupsGroup A: Fractional flow reserve-guided PCIActive comparator 1 intervention
Group B: Intravascular Ultrasound-guided PCIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient-Oriented Composite Outcome
a composite of death, myocardial infarction, or repeat revascularization
Time frame
2 years after last patient enrollmentSecondary outcomes
1
All-cause death
All-cause death
Time frame
2 years after last patient enrollment2
Cardiac death
Cardiac death
Time frame
2 years after last patient enrollment3
Spontaneous myocardial infarction
Spontaneous myocardial infarction, defined by Forth Universal definition of myocardial infarction
Time frame
2 years after last patient enrollment4
Procedure-related myocardial infarction
Procedure-related myocardial infarction, defined by ARC II definition
Time frame
2 years after last patient enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Samsung Medical Center
Lead sponsor
Chonnam National University
Collaborator
Source ClinicalTrials.gov