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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)

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ClinicalTrials.gov Identifier: NCT03767621
Recruitment Status : Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Fundación EPIC

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.


Condition or disease Intervention/treatment
Coronary Artery Disease Left Main Coronary Artery Stenosis Left Main Coronary Artery Disease Restenosis, Coronary Other: Indication of revascularization

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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)
Estimated Study Start Date : January 14, 2019
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : November 30, 2025

Group/Cohort Intervention/treatment
Patients with intermediate lesions.
Patients with intermediate lesions (stenosis in angiography between 25% and 60%) in LMCA.
Other: Indication of revascularization
Device: iFR/FFR




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767621


Contacts
Contact: Armando Pérez de Prado, PhD, MD +34987237400 aperez@secardiologia.es
Contact: Fundación EPIC +34987876135 iepic@fundacionepic.org

Sponsors and Collaborators
Fundación EPIC
Investigators
Principal Investigator: José María de la Torre, PhD, MD Hospital Universitario Marqués de Valdecilla
Principal Investigator: Oriol Rodríguez Leor, PhD, MD Germans Trias i Pujol Hospital

Publications:

Responsible Party: Fundación EPIC
ClinicalTrials.gov Identifier: NCT03767621     History of Changes
Other Study ID Numbers: iLITRO EPIC-07
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Keywords provided by Fundación EPIC:
Left Main Coronary Artery
Intermediate Coronary Lesions
iFR
Coronary Physiology
IVUS

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases