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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 (iLITRO Study)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Castellon, 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
Start Date
February 19, 2019
Primary Completion Date
June 30, 2026
Completion Date
November 30, 2026
Last Updated
March 5, 2025
300
ESTIMATED participants
Indication of revascularization
OTHER
Lead Sponsor
Fundación EPIC
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01311323