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NCT Number: 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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Restenosis Coronary Stenosis Heart Diseases Left Main Coronary Artery Disease Left Main Coronary Artery Stenosis Myocardial Ischemia Restenosis, Coronary Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Mutua de Terrassa, Terrassa, Barcelona, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indication of revascularization

Other

Device: iFR/FFR

Primary outcomes

  1. Assessment correlation between FFR>=0.80 and iFR >=0.89

    Time frame: 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.

  2. Major Adverse Cardiac Events

    Time frame: 30 days

    Composite of death, myocardial infarction, unplanned revascularisation

  3. Major Adverse Cardiac Events

    Time frame: 1 year

    Composite of death, myocardial infarction, unplanned revascularisation

  4. Major Adverse Cardiac Events

    Time frame: 5 years

    Composite of death, myocardial infarction, unplanned revascularisation

Secondary outcomes

  1. Assessment correlation between iFR and IVUS

    Time frame: 5 years

    Assessment correlation between iFR and IVUS derived minimal luminal area

  2. Death (all cause)

    Time frame: 30 days, 1 and 5 years

    Death (all cause)

  3. Death (cardiovascular)

    Time frame: 30 days, 1 and 5 years

    Death (cardiovascular)

  4. Non-fatal Myocardial Infarction

    Time frame: 30 days, 1 and 5 years

    Non-fatal Myocardial Infarction

  5. Non-fatal Myocardial Infarction related to the LMCA lesion

    Time frame: 30 days, 1 and 5 years

    Non-fatal Myocardial Infarction related to the LMCA lesion

  6. Revascularization

    Time frame: 30 days, 1 and 5 years

    Revascularization

  7. Revascularization of the target lesion

    Time frame: 30 days, 1 and 5 years

    Revascularization of the target lesion

  8. Myocardial Infarction related to target lesion revascularization

    Time frame: 30 days, 1 and 5 years

    Myocardial Infarction related to target lesion revascularization

  9. Stent Thrombosis in the target lesion revascularization

    Time frame: 30 days, 1 and 5 years

    Stent Thrombosis in the target lesion revascularization

  10. Restenosis of the stent in target lesion

    Time frame: 30 days, 1 and 5 years

    Restenosis of the stent in target lesion

  11. New revascularization of the target lesion

    Time frame: 30 days, 1 and 5 years

    New revascularization of the target lesion

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study 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)

Acronym: iLITRO

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2018
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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