An observational study in Coronary Artery Disease, Left Main Coronary Artery Stenosis and Left Main Coronary Artery Disease, sponsored by Fundación EPIC. Active, not recruiting at 38 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by Fundación EPIC · Observational
The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations.
Studies with a limited number of patients have shown that a value of FFR (Fractional Flow Reserve) above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.
The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations. In the case of intermediate stenoses (25-60%), invasive imaging tests, intravascular ultrasound (IVUS) or optical coherence tomography (OCT) or functional by determining the Fractional Flow Reserve (FFR), have been proposed to identify those patients who could benefit from revascularization.
Studies with a limited number of patients have shown that a value of FFR above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR in assessing the prognosis of patients with intermediate lesions, the validation of the prognostic power of this index in patients with intermediate LMCA lesions has not been demonstrated, although it is used in clinical practice assuming the results in other locations of the lesions.
The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 300 is below the median of 336 across 1,947 observational 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.
Patients with intermediate stenosis of the LMCA will be included by coronary angiography (estimate visual 25-60%) in which a functional study is performed with pressure and calculation guidance of iFR and FFR with intravenous adenosine in perfusion to guide the indication of revascularization.
Exclusion Criteria:
Patients with intermediate lesions (stenosis in angiography between 25% and 60%) in LMCA.
Other: Indication of revascularization
Device: iFR/FFR
Assessment correlation between FFR>=0.80 and iFR >=0.89
Efficacy and correlation of two invasive indexes of functional assessment by intracoronary pressure guidance in intermediate lesions of the LMCA with a cut-off point to defer the treatment of FFR\> = 0.80 (with intravenous adenosine) and iFR \> = 0.89. the LMCA.
Time frame: 1 day
Major Adverse Cardiac Events
Composite of death, myocardial infarction, unplanned revascularisation
Time frame: 30 days
Major Adverse Cardiac Events
Composite of death, myocardial infarction, unplanned revascularisation
Time frame: 1 year
Major Adverse Cardiac Events
Composite of death, myocardial infarction, unplanned revascularisation
Time frame: 5 years
Assessment correlation between iFR and IVUS
Assessment correlation between iFR and IVUS derived minimal luminal area
Time frame: 5 years
Death (all cause)
Death (all cause)
Time frame: 30 days, 1 and 5 years
Death (cardiovascular)
Death (cardiovascular)
Time frame: 30 days, 1 and 5 years
Non-fatal Myocardial Infarction
Non-fatal Myocardial Infarction
Time frame: 30 days, 1 and 5 years
Non-fatal Myocardial Infarction related to the LMCA lesion
Non-fatal Myocardial Infarction related to the LMCA lesion
Time frame: 30 days, 1 and 5 years
Revascularization
Revascularization
Time frame: 30 days, 1 and 5 years
Revascularization of the target lesion
Revascularization of the target lesion
Time frame: 30 days, 1 and 5 years
Myocardial Infarction related to target lesion revascularization
Myocardial Infarction related to target lesion revascularization
Time frame: 30 days, 1 and 5 years
Stent Thrombosis in the target lesion revascularization
Stent Thrombosis in the target lesion revascularization
Time frame: 30 days, 1 and 5 years
Restenosis of the stent in target lesion
Restenosis of the stent in target lesion
Time frame: 30 days, 1 and 5 years
New revascularization of the target lesion
New revascularization of the target lesion
Time frame: 30 days, 1 and 5 years
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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