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

NCT03767621 | Active Not Recruiting DMC

• 1 other identifier: iLITRO EPIC-07
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 38

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.

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

Outcome Measures

Primary Outcomes (4)

• Assessment correlation between FFR>=0.80 and iFR >=0.89

  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.

  1 day

• Major Adverse Cardiac Events

  Composite of death, myocardial infarction, unplanned revascularisation

  30 days

• Major Adverse Cardiac Events

  Composite of death, myocardial infarction, unplanned revascularisation

  1 year

• Major Adverse Cardiac Events

  Composite of death, myocardial infarction, unplanned revascularisation

  5 years

Secondary Outcomes (11)

• Assessment correlation between iFR and IVUS

  5 years

• Death (all cause)

  30 days, 1 and 5 years

• Death (cardiovascular)

  30 days, 1 and 5 years

• Non-fatal Myocardial Infarction

  30 days, 1 and 5 years

• Non-fatal Myocardial Infarction related to the LMCA lesion

  30 days, 1 and 5 years

Study Arms (1)

Patients with intermediate lesions.

Patients with intermediate lesions (stenosis in angiography between 25% and 60%) in LMCA.

Other: Indication of revascularization

Interventions

Indication of revascularization OTHER

Device: iFR/FFR

Patients with intermediate lesions.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (38)

Hospital Universitari Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital General Universitario de Santa Lucia de Cartagena

Cartagena, Murcia, 30202, Spain

Location

Hospital Clinico Universitario Virgen de La Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital General Universitario de Castellón

Castellon, Valencia, 12004, Spain

Location

Hospital Galdakao-Usansolo

Galdakao, Vizcaya, 48960, Spain

Location

Hospital General Universitario de Albacete

Albacete, 02006, Spain

Location

Hospital Universitario de Badajoz

Badajoz, 06080, Spain

Location

Hospital Universitari Germans Trias I Pujol de Badalona

Badalona, 08916, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, 08028, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitari Bellvitge

Barcelona, 08908, Spain

Location

Hospital Universitario Puerto Real

Cadiz, 11510, Spain

Location

Hospital General de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario de Cabueñes

Gijón, 33203, Spain

Location

Hospital Universitari Doctor Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario Virgen de Las Nieves

Granada, 18014, Spain

Location

Hospital General Juan Ramón Jiménez

Huelva, 21005, Spain

Location

Hospital de León

León, 24080, Spain

Location

Hospital Universitari Lucus Agusti

Lugo, 27003, Spain

Location

Hospital de La Princesa

Madrid, 28006, Spain

Location

Clinica Universitaria de Navarra

Madrid, 28027, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario de La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen de La Victoria

Málaga, 29010, Spain

Location

Hospital de Merida

Mérida, 06800, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Universitario de Donostia

San Sebastián, 20014, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Universitari Joan Xxiii de Tarragona

Tarragona, 43005, Spain

Location

Hospital Universitario Virgen de La Salud

Toledo, 45004, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitari I Politecnic La Fe

Valencia, 46026, Spain

Location

Hospital Universitario Alvaro Cunqueiro

Vigo, 36312, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (11)

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  PMID: 36111801 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Stenosis

Study Officials

• José María de la Torre, PhD, MD

  Hospital Universitario Marqués de Valdecilla

  PRINCIPAL INVESTIGATOR

• Oriol Rodríguez Leor, PhD, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2018
• First Posted: December 6, 2018
• Study Start: February 19, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

ES (38)