<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03767621</url>
  </required_header>
  <id_info>
    <org_study_id>iLITRO EPIC-07</org_study_id>
    <nct_id>NCT03767621</nct_id>
  </id_info>
  <brief_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</brief_title>
  <acronym>iLITRO</acronym>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación EPIC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación EPIC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography&#xD;
      renders serious limitations.&#xD;
&#xD;
      Studies with a limited number of patients have shown that a value of FFR (Fractional Flow&#xD;
      Reserve) above 0.80 identify a low risk of events in case of not performing revascularization&#xD;
      in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio)&#xD;
      has recently been found equivalent to FFR The demonstration of the prognostic utility of iFR&#xD;
      in patients with LMCA intermediate lesions could have an important clinical impact and&#xD;
      justify its systematic use for the treatment decision in these high-risk patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography&#xD;
      renders serious limitations. In the case of intermediate stenoses (25-60%), invasive imaging&#xD;
      tests, intravascular ultrasound (IVUS) or optical coherence tomography (OCT) or functional by&#xD;
      determining the Fractional Flow Reserve (FFR), have been proposed to identify those patients&#xD;
      who could benefit from revascularization.&#xD;
&#xD;
      Studies with a limited number of patients have shown that a value of FFR above 0.80 identify&#xD;
      a low risk of events in case of not performing revascularization in patients with&#xD;
      intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been&#xD;
      found equivalent to FFR in assessing the prognosis of patients with intermediate lesions, the&#xD;
      validation of the prognostic power of this index in patients with intermediate LMCA lesions&#xD;
      has not been demonstrated, although it is used in clinical practice assuming the results in&#xD;
      other locations of the lesions.&#xD;
&#xD;
      The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions&#xD;
      could have an important clinical impact and justify its systematic use for the treatment&#xD;
      decision in these high-risk patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Anticipated">November 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Assessment correlation between FFR&gt;=0.80 and iFR &gt;=0.89</measure>
    <time_frame>1 day</time_frame>
    <description>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&gt; = 0.80 (with intravenous adenosine) and iFR &gt; = 0.89. the LMCA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Major Adverse Cardiac Events</measure>
    <time_frame>30 days</time_frame>
    <description>Composite of death, myocardial infarction, unplanned revascularisation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Major Adverse Cardiac Events</measure>
    <time_frame>1 year</time_frame>
    <description>Composite of death, myocardial infarction, unplanned revascularisation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Major Adverse Cardiac Events</measure>
    <time_frame>5 years</time_frame>
    <description>Composite of death, myocardial infarction, unplanned revascularisation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment correlation between iFR and IVUS</measure>
    <time_frame>5 years</time_frame>
    <description>Assessment correlation between iFR and IVUS derived minimal luminal area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death (all cause)</measure>
    <time_frame>30 days, 1 and 5 years</time_frame>
    <description>Death (all cause)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death (cardiovascular)</measure>
    <time_frame>30 days, 1 and 5 years</time_frame>
    <description>Death (cardiovascular)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-fatal Myocardial Infarction</measure>
    <time_frame>30 days, 1 and 5 years</time_frame>
    <description>Non-fatal Myocardial Infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-fatal Myocardial Infarction related to the LMCA lesion</measure>
    <time_frame>30 days, 1 and 5 years</time_frame>
    <description>Non-fatal Myocardial Infarction related to the LMCA lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revascularization</measure>
    <time_frame>30 days, 1 and 5 years</time_frame>
    <description>Revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revascularization of the target lesion</measure>
    <time_frame>30 days, 1 and 5 years</time_frame>
    <description>Revascularization of the target lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial Infarction related to target lesion revascularization</measure>
    <time_frame>30 days, 1 and 5 years</time_frame>
    <description>Myocardial Infarction related to target lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Thrombosis in the target lesion revascularization</measure>
    <time_frame>30 days, 1 and 5 years</time_frame>
    <description>Stent Thrombosis in the target lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Restenosis of the stent in target lesion</measure>
    <time_frame>30 days, 1 and 5 years</time_frame>
    <description>Restenosis of the stent in target lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New revascularization of the target lesion</measure>
    <time_frame>30 days, 1 and 5 years</time_frame>
    <description>New revascularization of the target lesion</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Left Main Coronary Artery Stenosis</condition>
  <condition>Left Main Coronary Artery Disease</condition>
  <condition>Restenosis, Coronary</condition>
  <arm_group>
    <arm_group_label>Patients with intermediate lesions.</arm_group_label>
    <description>Patients with intermediate lesions (stenosis in angiography between 25% and 60%) in LMCA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Indication of revascularization</intervention_name>
    <description>Device: iFR/FFR</description>
    <arm_group_label>Patients with intermediate lesions.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with intermediate stenosis of the LMCA will be included by coronary angiography&#xD;
        (estimate visual 25-60%) in which a functional study is performed with pressure and&#xD;
        calculation guidance of iFR and FFR with intravenous adenosine in perfusion to guide the&#xD;
        indication of revascularization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with intermediate lesion in the LMCA (25-60% angiographic stenosis) by visual&#xD;
             estimation) in which the realization of a study with guide of pressure for the&#xD;
             determination of the iFR.&#xD;
&#xD;
          -  Patients aged ≥18 years.&#xD;
&#xD;
          -  Patients able of giving informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with indication for coronary surgery regardless of the significance of the&#xD;
             LMCA lesion.&#xD;
&#xD;
          -  Patients with a LMCA lesion presenting with ulceration, dissection or thrombus.&#xD;
&#xD;
          -  Patients with previous arterial or venous graft lesion functioning in the territory&#xD;
             irrigated by the LMCA (LMCA protected).&#xD;
&#xD;
          -  Patients with ACS (Acute Coronary Syndrome) with a potentially guilty lesion in the&#xD;
             LMCA.&#xD;
&#xD;
          -  Patients unable to obtain informed consent.&#xD;
&#xD;
          -  Patients with known terminal illness that conditions a life expectancy less than 1&#xD;
             year.&#xD;
&#xD;
          -  Patients with hemodynamic instability with Killip III or IV class.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>José María de la Torre, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Marqués de Valdecilla</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Oriol Rodríguez Leor, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Germans Trias i Pujol Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitari Mutua de Terrassa</name>
      <address>
        <city>Terrassa</city>
        <state>Barcelona</state>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Santa Lucia de Cartagena</name>
      <address>
        <city>Cartagena</city>
        <state>Murcia</state>
        <zip>30202</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Virgen de La Arrixaca</name>
      <address>
        <city>El Palmar</city>
        <state>Murcia</state>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Castellón</name>
      <address>
        <city>Castellón De La Plana</city>
        <state>Valencia</state>
        <zip>12004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Galdakao-Usansolo</name>
      <address>
        <city>Galdakao</city>
        <state>Vizcaya</state>
        <zip>48960</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Albacete</name>
      <address>
        <city>Albacete</city>
        <zip>02006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Badajoz</name>
      <address>
        <city>Badajoz</city>
        <zip>06080</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias I Pujol de Badalona</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic I Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall D'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de La Santa Creu I Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerto Real</name>
      <address>
        <city>Cadiz</city>
        <zip>11510</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Ciudad Real</name>
      <address>
        <city>Ciudad Real</city>
        <zip>13005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Cabueñes</name>
      <address>
        <city>Gijón</city>
        <zip>33203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Doctor Josep Trueta</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de Las Nieves</name>
      <address>
        <city>Granada</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Juan Ramón Jiménez</name>
      <address>
        <city>Huelva</city>
        <zip>21005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de León</name>
      <address>
        <city>León</city>
        <zip>24080</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Lucus Agusti</name>
      <address>
        <city>Lugo</city>
        <zip>27003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitaria de Navarra</name>
      <address>
        <city>Madrid</city>
        <zip>28027</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de La Victoria</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Merida</name>
      <address>
        <city>Mérida</city>
        <zip>06800</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Donostia</name>
      <address>
        <city>San Sebastián</city>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marqués de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Santiago de Compostela</name>
      <address>
        <city>Santiago De Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Joan Xxiii de Tarragona</name>
      <address>
        <city>Tarragona</city>
        <zip>43005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de La Salud</name>
      <address>
        <city>Toledo</city>
        <zip>45004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari I Politecnic La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Alvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
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  </reference>
  <reference>
    <citation>Gotberg M, Christiansen EH, Gudmundsdottir IJ, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Ohagen P, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Todt T, Venetsanos D, James SK, Karegren A, Nilsson M, Carlsson J, Hauer D, Jensen J, Karlsson AC, Panayi G, Erlinge D, Frobert O; iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823. doi: 10.1056/NEJMoa1616540. Epub 2017 Mar 18.</citation>
    <PMID>28317438</PMID>
  </reference>
  <reference>
    <citation>de la Torre Hernandez JM, Hernandez Hernandez F, Alfonso F, Rumoroso JR, Lopez-Palop R, Sadaba M, Carrillo P, Rondan J, Lozano I, Ruiz Nodar JM, Baz JA, Fernandez Nofrerias E, Pajin F, Garcia Camarero T, Gutierrez H; LITRO Study Group (Spanish Working Group on Interventional Cardiology). Prospective application of pre-defined intravascular ultrasound criteria for assessment of intermediate left main coronary artery lesions results from the multicenter LITRO study. J Am Coll Cardiol. 2011 Jul 19;58(4):351-8. doi: 10.1016/j.jacc.2011.02.064.</citation>
    <PMID>21757111</PMID>
  </reference>
  <reference>
    <citation>Hamilos M, Muller O, Cuisset T, Ntalianis A, Chlouverakis G, Sarno G, Nelis O, Bartunek J, Vanderheyden M, Wyffels E, Barbato E, Heyndrickx GR, Wijns W, De Bruyne B. Long-term clinical outcome after fractional flow reserve-guided treatment in patients with angiographically equivocal left main coronary artery stenosis. Circulation. 2009 Oct 13;120(15):1505-12. doi: 10.1161/CIRCULATIONAHA.109.850073. Epub 2009 Sep 28.</citation>
    <PMID>19786633</PMID>
  </reference>
  <reference>
    <citation>de la Torre Hernandez JM, Baz Alonso JA, Gomez Hospital JA, Alfonso Manterola F, Garcia Camarero T, Gimeno de Carlos F, Roura Ferrer G, Recalde AS, Martinez-Luengas IL, Gomez Lara J, Hernandez Hernandez F, Perez-Vizcayno MJ, Cequier Fillat A, Perez de Prado A, Gonzalez-Trevilla AA, Jimenez Navarro MF, Mauri Ferre J, Fernandez Diaz JA, Pinar Bermudez E, Zueco Gil J; IVUS-TRONCO-ICP Spanish study. Clinical impact of intravascular ultrasound guidance in drug-eluting stent implantation for unprotected left main coronary disease: pooled analysis at the patient-level of 4 registries. JACC Cardiovasc Interv. 2014 Mar;7(3):244-54. doi: 10.1016/j.jcin.2013.09.014.</citation>
    <PMID>24650399</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>July 26, 2022</last_update_submitted>
  <last_update_submitted_qc>July 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Left Main Coronary Artery</keyword>
  <keyword>Intermediate Coronary Lesions</keyword>
  <keyword>iFR</keyword>
  <keyword>Coronary Physiology</keyword>
  <keyword>IVUS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Stenosis</mesh_term>
    <mesh_term>Coronary Restenosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03767621
org study id: iLITRO EPIC-07
nct id: NCT03767621
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Assessment correlation between FFR>=0.80 and iFR >=0.89
time frame: 1 day
description: 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.
measure: Major Adverse Cardiac Events
time frame: 30 days
description: Composite of death, myocardial infarction, unplanned revascularisation
measure: Major Adverse Cardiac Events
time frame: 1 year
description: Composite of death, myocardial infarction, unplanned revascularisation
measure: Major Adverse Cardiac Events
time frame: 5 years
description: Composite of death, myocardial infarction, unplanned revascularisation
measure: Assessment correlation between iFR and IVUS
time frame: 5 years
description: Assessment correlation between iFR and IVUS derived minimal luminal area
measure: Death (all cause)
time frame: 30 days, 1 and 5 years
description: Death (all cause)
measure: Death (cardiovascular)
time frame: 30 days, 1 and 5 years
description: Death (cardiovascular)
measure: Non-fatal Myocardial Infarction
time frame: 30 days, 1 and 5 years
description: Non-fatal Myocardial Infarction
measure: Non-fatal Myocardial Infarction related to the LMCA lesion
time frame: 30 days, 1 and 5 years
description: Non-fatal Myocardial Infarction related to the LMCA lesion
measure: Revascularization
time frame: 30 days, 1 and 5 years
description: Revascularization
measure: Revascularization of the target lesion
time frame: 30 days, 1 and 5 years
description: Revascularization of the target lesion
measure: Myocardial Infarction related to target lesion revascularization
time frame: 30 days, 1 and 5 years
description: Myocardial Infarction related to target lesion revascularization
measure: Stent Thrombosis in the target lesion revascularization
time frame: 30 days, 1 and 5 years
description: Stent Thrombosis in the target lesion revascularization
measure: Restenosis of the stent in target lesion
time frame: 30 days, 1 and 5 years
description: Restenosis of the stent in target lesion
measure: New revascularization of the target lesion
time frame: 30 days, 1 and 5 years
description: New revascularization of the target lesion
arm group label: Patients with intermediate lesions.
description: Patients with intermediate lesions (stenosis in angiography between 25% and 60%) in LMCA.
intervention type: Other
intervention name: Indication of revascularization
description: Device: iFR/FFR
arm group label: Patients with intermediate lesions.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: José María de la Torre, PhD, MD
role: Principal Investigator
affiliation: Hospital Universitario Marqués de Valdecilla
last name: Oriol Rodríguez Leor, PhD, MD
role: Principal Investigator
affiliation: Germans Trias i Pujol Hospital
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country: Spain
citation: De Bruyne B, Baudhuin T, Melin JA, Pijls NH, Sys SU, Bol A, Paulus WJ, Heyndrickx GR, Wijns W. Coronary flow reserve calculated from pressure measurements in humans. Validation with positron emission tomography. Circulation. 1994 Mar;89(3):1013-22. doi: 10.1161/01.cir.89.3.1013.
PMID: 8124786
citation: Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
PMID: 25173339
citation: Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW, van't Veer M, Bar F, Hoorntje J, Koolen J, Wijns W, de Bruyne B. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. 2007 May 29;49(21):2105-11. doi: 10.1016/j.jacc.2007.01.087. Epub 2007 May 17.
PMID: 17531660
citation: Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
PMID: 19144937
citation: Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7.
PMID: 22154731
citation: Davies JE, Sen S, Dehbi HM, Al-Lamee R, Petraco R, Nijjer SS, Bhindi R, Lehman SJ, Walters D, Sapontis J, Janssens L, Vrints CJ, Khashaba A, Laine M, Van Belle E, Krackhardt F, Bojara W, Going O, Harle T, Indolfi C, Niccoli G, Ribichini F, Tanaka N, Yokoi H, Takashima H, Kikuta Y, Erglis A, Vinhas H, Canas Silva P, Baptista SB, Alghamdi A, Hellig F, Koo BK, Nam CW, Shin ES, Doh JH, Brugaletta S, Alegria-Barrero E, Meuwissen M, Piek JJ, van Royen N, Sezer M, Di Mario C, Gerber RT, Malik IS, Sharp ASP, Talwar S, Tang K, Samady H, Altman J, Seto AH, Singh J, Jeremias A, Matsuo H, Kharbanda RK, Patel MR, Serruys P, Escaned J. Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834. doi: 10.1056/NEJMoa1700445. Epub 2017 Mar 18.
PMID: 28317458
citation: Gotberg M, Christiansen EH, Gudmundsdottir IJ, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Ohagen P, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Todt T, Venetsanos D, James SK, Karegren A, Nilsson M, Carlsson J, Hauer D, Jensen J, Karlsson AC, Panayi G, Erlinge D, Frobert O; iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823. doi: 10.1056/NEJMoa1616540. Epub 2017 Mar 18.
PMID: 28317438
citation: de la Torre Hernandez JM, Hernandez Hernandez F, Alfonso F, Rumoroso JR, Lopez-Palop R, Sadaba M, Carrillo P, Rondan J, Lozano I, Ruiz Nodar JM, Baz JA, Fernandez Nofrerias E, Pajin F, Garcia Camarero T, Gutierrez H; LITRO Study Group (Spanish Working Group on Interventional Cardiology). Prospective application of pre-defined intravascular ultrasound criteria for assessment of intermediate left main coronary artery lesions results from the multicenter LITRO study. J Am Coll Cardiol. 2011 Jul 19;58(4):351-8. doi: 10.1016/j.jacc.2011.02.064.
PMID: 21757111
citation: Hamilos M, Muller O, Cuisset T, Ntalianis A, Chlouverakis G, Sarno G, Nelis O, Bartunek J, Vanderheyden M, Wyffels E, Barbato E, Heyndrickx GR, Wijns W, De Bruyne B. Long-term clinical outcome after fractional flow reserve-guided treatment in patients with angiographically equivocal left main coronary artery stenosis. Circulation. 2009 Oct 13;120(15):1505-12. doi: 10.1161/CIRCULATIONAHA.109.850073. Epub 2009 Sep 28.
PMID: 19786633
citation: de la Torre Hernandez JM, Baz Alonso JA, Gomez Hospital JA, Alfonso Manterola F, Garcia Camarero T, Gimeno de Carlos F, Roura Ferrer G, Recalde AS, Martinez-Luengas IL, Gomez Lara J, Hernandez Hernandez F, Perez-Vizcayno MJ, Cequier Fillat A, Perez de Prado A, Gonzalez-Trevilla AA, Jimenez Navarro MF, Mauri Ferre J, Fernandez Diaz JA, Pinar Bermudez E, Zueco Gil J; IVUS-TRONCO-ICP Spanish study. Clinical impact of intravascular ultrasound guidance in drug-eluting stent implantation for unprotected left main coronary disease: pooled analysis at the patient-level of 4 registries. JACC Cardiovasc Interv. 2014 Mar;7(3):244-54. doi: 10.1016/j.jcin.2013.09.014.
PMID: 24650399
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Coronary Stenosis
mesh term: Coronary Restenosis