Clinical trial NCT03767621: 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
Official title: 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Left Main Coronary Artery Stenosis
Left Main Coronary Artery Disease
Restenosis, Coronary
Keywords: Left Main Coronary Artery
Intermediate Coronary Lesions
iFR
Coronary Physiology
IVUS
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment correlation between FFR>=0.80 and iFR >=0.89
timeFrame: 1 day
measure: Major Adverse Cardiac Events
timeFrame: 30 days
measure: Major Adverse Cardiac Events
timeFrame: 1 year
measure: Major Adverse Cardiac Events
timeFrame: 5 years
Secondary outcomes:
measure: Assessment correlation between iFR and IVUS
timeFrame: 5 years
measure: Death (all cause)
timeFrame: 30 days, 1 and 5 years
measure: Death (cardiovascular)
timeFrame: 30 days, 1 and 5 years
measure: Non-fatal Myocardial Infarction
timeFrame: 30 days, 1 and 5 years
measure: Non-fatal Myocardial Infarction related to the LMCA lesion
timeFrame: 30 days, 1 and 5 years
measure: Revascularization
timeFrame: 30 days, 1 and 5 years
measure: Revascularization of the target lesion
timeFrame: 30 days, 1 and 5 years
measure: Myocardial Infarction related to target lesion revascularization
timeFrame: 30 days, 1 and 5 years
measure: Stent Thrombosis in the target lesion revascularization
timeFrame: 30 days, 1 and 5 years
measure: Restenosis of the stent in target lesion
timeFrame: 30 days, 1 and 5 years
measure: New revascularization of the target lesion
timeFrame: 30 days, 1 and 5 years
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua de Terrassa
state: Barcelona
city: Cartagena
country: Spain
facility: Hospital General Universitario de Santa Lucia de Cartagena
state: Murcia
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen de La Arrixaca
state: Murcia
city: Castellón De La Plana
country: Spain
facility: Hospital General Universitario de Castellón
state: Valencia
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
state: Vizcaya
city: Albacete
country: Spain
facility: Hospital General Universitario de Albacete
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol de Badalona
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Bellvitge
city: Cadiz
country: Spain
facility: Hospital Universitario Puerto Real
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
city: Girona
country: Spain
facility: Hospital Universitari Doctor Josep Trueta
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Huelva
country: Spain
facility: Hospital General Juan Ramón Jiménez
city: León
country: Spain
facility: Hospital de León
city: Lugo
country: Spain
facility: Hospital Universitari Lucus Agusti
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Madrid
country: Spain
facility: Clinica Universitaria de Navarra
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de La Victoria
city: Mérida
country: Spain
facility: Hospital de Merida
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: San Sebastián
country: Spain
facility: Hospital Universitario de Donostia
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago de Compostela
city: Tarragona
country: Spain
facility: Hospital Universitari Joan Xxiii de Tarragona
city: Toledo
country: Spain
facility: Hospital Universitario Virgen de La Salud
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari I Politecnic La Fe
city: Vigo
country: Spain
facility: Hospital Universitario Alvaro Cunqueiro
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
Study officials:
affiliation: Hospital Universitario Marqués de Valdecilla
name: José María de la Torre, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Germans Trias i Pujol Hospital
name: Oriol Rodríguez Leor, PhD, MD
role: PRINCIPAL_INVESTIGATOR
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