An interventional study of FFR>0.80+ OCT with findings indicative of vulnerable plaque and FFR>0.80+ OCT with findings indicative of vulnerable plaque in Coronary Artery Disease, Coronary Disease and Ischemic Heart Disease, sponsored by Fundación EPIC. Active, not recruiting at 49 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Fundación EPIC · Not applicable, Interventional, and Prevention
The study aims to compare a preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) strategy vs. OMT for treatment of non-functionally significant non-culprit lesions presenting with optical coherence tomography (OCT) findings indicative of vulnerable plaque, in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease.
STEMI patients with multivessel disease planned for invasive evaluation of intermediate lesions (40-69% stenosis) are initially investigated with fractional flow reserve (FFR). Patients with FFR ≤ 0.80 are considered as screening failure and treated with PCI. Patients with FFR > 0.80 are then investigated with optical coherence tomography (OCT). Patients without OCT findings of vulnerable plaque are treated with OMT and included in the OMT registry arm. Patients presenting with OCT characteristics of vulnerable plaque are included in the randomized trial comparing PCI with stent implantation plus OMT versus OMT.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 609 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Fundación EPIC is the lead sponsor of 48 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque
Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque
Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI
OPTIMAL MEDICAL TREATMENT (OMT)
Target Vessel Failure (TVF)
TVF as a composite of : Cardiovascular Death Target-vessel related MI Clinically and physiologically-oriented Target vessel revascularization
Time frame: 4 Years
Cardiac death
To compare Cardiac death between both groups in the randomized arm death.
Time frame: 4 Years
All-cause Death
To compare all death between both groups in the randomized arm death.
Time frame: 4 Years
All Myocardial Infarctions
To compare Myocardial Infarctions between both groups in the randomized arm death. death
Time frame: 4 Years
Target-Vessel Myocardial Infarction
To compare target-vessel myocardial infarction between both groups in the randomized arm.
Time frame: 4 Years
Revascularizations
To compare all revascularizations between both groups in the randomized arm.
Time frame: 4 Years
Ischemic-driven target vessel revascularization
To compare ischemic-driven target vessel revascularization between both groups in the randomized arm.
Time frame: 4 Years
Patient-oriented endpoint of major adverse cardiac events
To compare the patient-oriented endpoint of major adverse cardiac events, a composite of all-cause death, myocardial infarction, and revascularization between both groups in the randomized arm.
Time frame: 4 Years
Target Vessel Failure (TVF)
To compare the TVF rate between patients included in the OMT group of the randomized arm (presenting with vulnerable plaque) vs. patients included in the OMT registry (without vulnerable plaque).
Time frame: 4 Years
Fractional Flow Reserve (FFR)
To compare the FFR values between patients with vulnerable plaques (randomized arm) and patients without vulnerable plaques (OMT registry).
Time frame: 4 years
Minimal lumen area by Optical Coherence Tomography (OCT)
To establish the optimal OCT-derived minimal lumen area cutoff to predict an ischemic FFR in the non-culprit artery in the acute setting.
Time frame: 4 years
Accuracy of vulnerable plaque assessment by Optical Coherence Tomography (OCT)
To compare the agreement between local operators and the core-laboratory to assess vulnerable plaques by OCT.
Time frame: 4 years
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Fundación EPIC