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NCT03767621Active, not recruiting

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

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)

Source: ClinicalTrials.gov · Last updated 5 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
2 Dec 2018
Start date
19 Feb 2019
Primary completion date
30 Jun 2026
Lead sponsor
Fundación EPIC
NCT number
NCT03767621

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 19 Feb 2019 to the primary completion date, 30 Jun 2026
  • 38 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with indication for coronary surgery regardless of the significance of the LMCA lesion.
  • Patients with previous arterial or venous graft lesion functioning in the territory irrigated by the LMCA (LMCA protected).

Other illness

  • Patients with ACS (Acute Coronary Syndrome) with a potentially guilty lesion in the LMCA.
  • Patients with known terminal illness that conditions a life expectancy less than 1 year.

Other

  • Patients with a LMCA lesion presenting with ulceration, dissection or thrombus.
  • Patients unable to obtain informed consent.
  • Patients with hemodynamic instability with Killip III or IV class.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital General Universitario de Albacete
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AlbaceteSpainUnknown status
Hospital Universitario de Badajoz
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BadajozSpainUnknown status
Hospital Universitari Germans Trias i Pujol de Badalona
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BadalonaSpainUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Hospital Universitari Bellvitge
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BarcelonaSpainUnknown status
Hospital Clínic i Provincial de Barcelona
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BarcelonaSpainUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital del Mar
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BarcelonaSpainUnknown status
Hospital Universitario Puerto Real
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CadizSpainUnknown status
Hospital General Universitario de Santa Lucia de Cartagena
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CartagenaSpainUnknown status
Hospital General Universitario de Castellón
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CastellonSpainUnknown status
Hospital General de Ciudad Real
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Ciudad RealSpainUnknown status
Hospital Universitario Reina Sofia
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CórdobaSpainUnknown status
Hospital Clínico Universitario Virgen de la Arrixaca
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El PalmarSpainUnknown status
Hospital Galdakao-Usansolo
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GaldakaoSpainUnknown status
Hospital Universitario de Cabueñes
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GijónSpainUnknown status
Hospital Universitari Doctor Josep Trueta
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GironaSpainUnknown status
Hospital Universitario Virgen de las Nieves
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GranadaSpainUnknown status
Hospital General Juan Ramon Jimenez
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HuelvaSpainUnknown status
Hospital de León
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LeónSpainUnknown status
Hospital Universitari Lucus Agusti
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LugoSpainUnknown status
Hospital Universitario de la Paz
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MadridSpainUnknown status
Hospital Clínico San Carlos
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MadridSpainUnknown status
Clínica Universitaria de Navarra
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MadridSpainUnknown status
Hospital de La Princesa
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MadridSpainUnknown status
Hospital Universitario Virgen de la Victoria
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MálagaSpainUnknown status
Hospital de Mérida
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MéridaSpainUnknown status
Hospital Universitario Central De Asturias
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OviedoSpainUnknown status
Hospital Universitario de Donostia
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San SebastiánSpainUnknown status
Hospital Universitario Marqués de Valdecilla
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SantanderSpainUnknown status
Hospital Clínico Universitario de Santiago de Compostela
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Santiago de CompostelaSpainUnknown status
Hospital Universitari Joan XXIII de Tarragona
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TarragonaSpainUnknown status
Hospital Universitari Mútua de Terrassa
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TerrassaSpainUnknown status
Hospital Universitario Virgen de La Salud
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ToledoSpainUnknown status
Hospital Universitari i Politécnic La Fe
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ValenciaSpainUnknown status
Hospital Clinico Universitario de Valencia
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ValenciaSpainUnknown status
Hospital Universitario Alvaro Cunqueiro
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VigoSpainUnknown status
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.