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
- Conditions
- Left Main Coronary Artery StenosisLeft Main Coronary Artery DiseaseRestenosis, CoronaryCoronary Artery Disease
- Interventions
- Other: Indication of revascularization
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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
- Arm && Interventions
Group Intervention Description Patients with intermediate lesions. Indication of revascularization Patients with intermediate lesions (stenosis in angiography between 25% and 60%) in LMCA.
- 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 Restenosis of the stent in target lesion 30 days, 1 and 5 years Restenosis of the stent in target lesion
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
Trial Locations
- Locations (38)
Hospital General Universitario de Santa Lucia de Cartagena
🇪🇸Cartagena, Murcia, Spain
Hospital Clinico Universitario Virgen de La Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital Universitari Doctor Josep Trueta
🇪🇸Girona, Spain
Hospital Universitari Mutua de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital General Universitario de Castellón
🇪🇸Castellón De La Plana, Valencia, Spain
Hospital Galdakao-Usansolo
🇪🇸Galdakao, Vizcaya, Spain
Hospital Universitario de Badajoz
🇪🇸Badajoz, Spain
Hospital General Universitario de Albacete
🇪🇸Albacete, Spain
Hospital Universitari Germans Trias I Pujol de Badalona
🇪🇸Badalona, Spain
Hospital Universitari Bellvitge
🇪🇸Barcelona, Spain
Hospital Del Mar
🇪🇸Barcelona, Spain
Hospital Clinic I Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitari Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Puerto Real
🇪🇸Cadiz, Spain
Hospital General de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
Hospital Universitario de Cabueñes
🇪🇸Gijón, Spain
Hospital Universitario Virgen de Las Nieves
🇪🇸Granada, Spain
Hospital General Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital de León
🇪🇸León, Spain
Hospital Universitari Lucus Agusti
🇪🇸Lugo, Spain
Hospital de La Princesa
🇪🇸Madrid, Spain
Clinica Universitaria de Navarra
🇪🇸Madrid, Spain
Hospital Universitario de La Paz
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Virgen de La Victoria
🇪🇸Málaga, Spain
Hospital de Merida
🇪🇸Mérida, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Clinico Universitario de Santiago de Compostela
🇪🇸Santiago De Compostela, Spain
Hospital Universitario Virgen de La Salud
🇪🇸Toledo, Spain
Hospital Universitario de Donostia
🇪🇸San Sebastián, Spain
Hospital Universitari Joan Xxiii de Tarragona
🇪🇸Tarragona, Spain
Hospital Universitari I Politecnic La Fe
🇪🇸Valencia, Spain
Hospital Universitario Alvaro Cunqueiro
🇪🇸Vigo, Spain
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain