Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR

Active, not recruiting

• Conditions: Left Main Coronary Artery Stenosis; Left Main Coronary Artery Disease; Restenosis, Coronary; Coronary Artery Disease

• Registration Number: NCT03767621
• Lead Sponsor: Fundación EPIC

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-12-02
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Study Start: 2019-02-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-06-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients with intermediate lesion in the LMCA (25-60% angiographic stenosis) by visual estimation) in which the realization of a study with guide of pressure for the determination of the iFR.
• Patients aged ≥18 years.
• Patients able of giving informed consent.

Exclusion Criteria

• Patients with indication for coronary surgery regardless of the significance of the LMCA lesion.
• Patients with a LMCA lesion presenting with ulceration, dissection or thrombus.
• Patients with previous arterial or venous graft lesion functioning in the territory irrigated by the LMCA (LMCA protected).
• Patients with ACS (Acute Coronary Syndrome) with a potentially guilty lesion in the LMCA.
• Patients unable to obtain informed consent.
• Patients with known terminal illness that conditions a life expectancy less than 1 year.
• Patients with hemodynamic instability with Killip III or IV class.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events	5 years	Composite of death, myocardial infarction, unplanned revascularisation
Assessment correlation between FFR>=0.80 and iFR >=0.89	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Assessment correlation between iFR and IVUS	5 years	Assessment correlation between iFR and IVUS derived minimal luminal area
Death (cardiovascular)	30 days, 1 and 5 years	Death (cardiovascular)
Myocardial Infarction related to target lesion revascularization	30 days, 1 and 5 years	Myocardial Infarction related to target lesion revascularization
Stent Thrombosis in the target lesion revascularization	30 days, 1 and 5 years	Stent Thrombosis in the target lesion revascularization
Non-fatal Myocardial Infarction	30 days, 1 and 5 years	Non-fatal Myocardial Infarction
Revascularization of the target lesion	30 days, 1 and 5 years	Revascularization of the target lesion
Death (all cause)	30 days, 1 and 5 years	Death (all cause)
New revascularization of the target lesion	30 days, 1 and 5 years	New revascularization of the target lesion
Non-fatal Myocardial Infarction related to the LMCA lesion	30 days, 1 and 5 years	Non-fatal Myocardial Infarction related to the LMCA lesion
Revascularization	30 days, 1 and 5 years	Revascularization
Restenosis of the stent in target lesion	30 days, 1 and 5 years	Restenosis of the stent in target lesion

Trial Locations

Locations (38)

Hospital Universitari Mutua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital General Universitario de Santa Lucia de Cartagena; 🇪🇸 Cartagena, Murcia, Spain

Hospital Clinico Universitario Virgen de La Arrixaca; 🇪🇸 El Palmar, Murcia, Spain

Hospital General Universitario de Castellón; 🇪🇸 Castellón De La Plana, Valencia, Spain

Hospital Galdakao-Usansolo; 🇪🇸 Galdakao, Vizcaya, Spain

Hospital General Universitario de Albacete; 🇪🇸 Albacete, Spain

Hospital Universitario de Badajoz; 🇪🇸 Badajoz, Spain

Hospital Universitari Germans Trias I Pujol de Badalona; 🇪🇸 Badalona, Spain

Hospital Del Mar; 🇪🇸 Barcelona, Spain

Hospital Clinic I Provincial de Barcelona; 🇪🇸 Barcelona, Spain

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