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)

Fundación EPIC

Status: Active, not recruiting

Conditions: Restenosis, Coronary; Left Main Coronary Artery Stenosis; Coronary Artery Disease; Left Main Coronary Artery Disease

Treatments: Other: Indication of revascularization

Study type: Observational

Funder types: Other

Identifiers

NCT03767621

iLITRO EPIC-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Patients with intermediate lesions.

Description:

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

Treatment:

Other: Indication of revascularization