<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/NCT03820492</url>
  </required_header>
  <id_info>
    <org_study_id>OPTICO-LM</org_study_id>
    <nct_id>NCT03820492</nct_id>
  </id_info>
  <brief_title>Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT</brief_title>
  <acronym>OPTICO-LM</acronym>
  <official_title>Multimodality Assessment of Intermediate Left Main Stenosis: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate&#xD;
      judgement of the prognostic significance of LM stenosis is essential to improve patients'&#xD;
      prognosis. Recently, fractional flow reserve (FFR) has become widespread practice and carries&#xD;
      a Class Ia recommendation to assess functional significance of intermediate coronary stenosis&#xD;
      in patients with stable angina. Intravascular ultrasound (IVUS)-derived minimum lumen area&#xD;
      (MLA) represents an accurate measure to determine LM significance as shown in multiple&#xD;
      studies, while optical coherence tomography (OCT) ,which is a novel intracoronary imaging&#xD;
      method with a greater spatial resolution (15μm vs. 100μm), faster image acquisition and&#xD;
      facilitated image interpretation, OCT derived-MLA has never been validated against FFR and&#xD;
      accordingly, it is not mentioned in the current guidelines for myocardial revascularization.&#xD;
      Coronary computed tomography angiography (CTA) has emerged as a noninvasive alternative of&#xD;
      coronary angiography with its excellent negative predictive value, while the positive&#xD;
      predictive value of CTA is limited. Computational fluid dynamics is an emerging method that&#xD;
      enables prediction of blood flow in coronary arteries and calculation of FFR from computed&#xD;
      tomography (FFRCT) noninvasively. Noninvasive and accurate assessment of functional&#xD;
      significance would bring a great benefit for patients with LM stenosis, however, there are no&#xD;
      data to evaluate the diagnostic accuracy of FFRCT for LM stenosis in comparison with FFR and&#xD;
      minimal lumen area derived by OCT.&#xD;
&#xD;
      This study will investigate the optimal OCT-derived MLA cut-off point and the diagnostic&#xD;
      performance of FFRCT for intermediate LM stenosis compared with FFR ≤0.8 as a reference&#xD;
      standard.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 28, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>OCT vs. FFR</measure>
    <time_frame>Measurement at Procedure/ Baseline Visit</time_frame>
    <description>- The area under the curve of OCT-derived MLA for FFR≤0.8</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OCT vs. FFR</measure>
    <time_frame>Measurement at Procedure/ Baseline Visit</time_frame>
    <description>-The optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.8</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FFRCT vs. FFR</measure>
    <time_frame>Measurement at Procedure/ Baseline Visit</time_frame>
    <description>Diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of FFRCT≤0.8 for FFR≤0.8</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OCT vs. FFR, RFR, resting Pd/Pa, FFRCT, QFR</measure>
    <time_frame>Measurement at Procedure/ Baseline Visit</time_frame>
    <description>- The area under the curve and the optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OCT vs. FFR, RFR, resting Pd/Pa, FFRCT</measure>
    <time_frame>Measurement at Procedure/ Baseline Visit</time_frame>
    <description>- Predictability of MLA, minimal lumen diameter, area stenosis, lesion length, eccentricity index, and plaque characteristics (plaque rupture, fibroatheroma, and calcification) for FFR ≤0.8, FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OCT vs. FFR, RFR, resting Pd/Pa, FFRCT</measure>
    <time_frame>Measurement at Procedure/ Baseline Visit</time_frame>
    <description>- Correlation among OCT-derived MLA, FFR, RFR, resting Pd/Pa, and FFRCT and QFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OCT vs. CTA</measure>
    <time_frame>Measurement at Procedure/ Baseline Visit</time_frame>
    <description>- Correlation between luminal diameter stenosis of CTA and OCT-derived MLA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OCT vs. CTA</measure>
    <time_frame>Measurement at Procedure/ Baseline Visit</time_frame>
    <description>- Diagnostic accuracy of plaque characteristics with presumed high risk characteristics including napkin ring sign, low attenuation plaque (&lt;30HU), positive remodelling (remodelling index &gt;1.1), and spotty calcium (&lt;3mm) for thin and thick cap fibroatheroma by OCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoint at 1 year</measure>
    <time_frame>12 Month</time_frame>
    <description>Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoint at 1 year</measure>
    <time_frame>12 Month</time_frame>
    <description>Myocardial infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoint at 1 year</measure>
    <time_frame>12 Month</time_frame>
    <description>Target vessel myocardial infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoint at 1 year</measure>
    <time_frame>12 Month</time_frame>
    <description>Target lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoint at 1 year</measure>
    <time_frame>12 Month</time_frame>
    <description>Target vessel revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoint at 1 year</measure>
    <time_frame>12 Month</time_frame>
    <description>Any revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoint at 1 year</measure>
    <time_frame>12 Month</time_frame>
    <description>Stent thrombosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoint at 1 year</measure>
    <time_frame>12 Month</time_frame>
    <description>Stroke and transient ischemic attack</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoint at 1 year</measure>
    <time_frame>12 Month</time_frame>
    <description>Acute renal failure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Coronary Stenosis</condition>
  <arm_group>
    <arm_group_label>Patient with left-main stenosis</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>OCT, FFR, CTA and FFRCT</intervention_name>
    <description>Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT</description>
    <arm_group_label>Patient with left-main stenosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unprotected LM lesion [midshaft, and distal bifurcation (Medina 1,1,1 or 1,1,0 or&#xD;
             1,0,1 or 1,0,0)] of 30% to 80% angiographic diameter stenosis (DS) on visual&#xD;
             estimation or equivocal disease by angiography.&#xD;
&#xD;
          -  Age ≥18 years.&#xD;
&#xD;
          -  Ability to give preliminary oral consent witnessed by an independent physician or sign&#xD;
             written informed consent prior to any study-specific procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant distal lesions (&gt;50% angiographic DS on visual estimation within the left&#xD;
             anterior descending artery [LAD] or left circumflex artery [LCX], except for ostium of&#xD;
             LAD or LCX or diseased side branch [e.g. diagonal branch, obtuse marginal branch])&#xD;
&#xD;
          -  Ostial LM disease.&#xD;
&#xD;
          -  Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI).&#xD;
&#xD;
          -  LM In-stent restenosis.&#xD;
&#xD;
          -  Previous coronary stenting of the left coronary system.&#xD;
&#xD;
          -  Chronic total occlusion.&#xD;
&#xD;
          -  Previous coronary artery bypass graft.&#xD;
&#xD;
          -  Previous MI related to the left coronary artery.&#xD;
&#xD;
          -  Occurrence of ventricularization or hypotension during engagement of the LM ostial&#xD;
             lesion.&#xD;
&#xD;
          -  The presence of hemodynamic instability.&#xD;
&#xD;
          -  Known renal insufficiency (serum creatinine &gt;1.5mg/dL or receiving dialysis).&#xD;
&#xD;
          -  Female of childbearing potential (age &lt;50 years and last menstruation within the last&#xD;
             12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.&#xD;
&#xD;
          -  Life expectancy less than 1 year.&#xD;
&#xD;
          -  Contraindication or known allergy against protocol-required medications including&#xD;
             heparin, iodinated contrast, β-blocker, nitroglycerin, and adenosine.&#xD;
&#xD;
          -  Body mass index &gt;35kg/m2.&#xD;
&#xD;
          -  Complex congenital heart disease other than anomalous coronary origins alone.&#xD;
&#xD;
          -  Ventricular septal defect.&#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>Lorenz Raeber, Prof. MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inselspital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lorenz Raeber, Prof. MD PhD</last_name>
    <phone>+41316322111</phone>
    <email>lorenz.raeber@insel.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hiroki Shinutani, MD</last_name>
    <phone>+41316322111</phone>
    <email>hiroki.shibutani@extern.insel.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Géraud Souteyrand, Prof.</last_name>
      <email>gsouteyrand@chu-clermontferrand.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institute Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas Amabile, Dr. med.</last_name>
      <email>nicolasamabile@yahoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Cardiologique du Nord</name>
      <address>
        <city>Saint-Denis</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Franck Digne, Dr. med</last_name>
      <email>f.digne@ccn.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Giessen Justus-Liebig Universität</name>
      <address>
        <city>Gießen</city>
        <state>Hesse</state>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nef Holger, Professor</last_name>
      <phone>641 98556220</phone>
      <phone_ext>+49</phone_ext>
      <email>Holger.Nef@innere.med.uni-giessen.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephan Achenbach, Prof.</last_name>
      <email>Stephan.Achenbach@uk-erlangen.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ageo Central General Hospital</name>
      <address>
        <city>Ageo</city>
        <zip>362-8588</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Masataka Nakano, Dr. med</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gifu heart center</name>
      <address>
        <city>Gifu</city>
        <zip>500-8384</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matsuo Hitoshi, Dr.</last_name>
      <phone>58-277-2277</phone>
      <phone_ext>+81</phone_ext>
      <email>matsuo@heart-center.or.jp</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Cardiovascular Medicine Shinshu University School of Medicine</name>
      <address>
        <city>Nagano</city>
        <zip>390-8621</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yasushi Ueki, Dr. med. PhD</last_name>
      <email>yasushi522@shinshu-u.ac.jp</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University,</name>
      <address>
        <city>Osaka</city>
        <zip>573-1010</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kenichi Fuji, Dr.med</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical Corporation Ouyuukai Tokorozawa Heart Center</name>
      <address>
        <city>Saitama</city>
        <zip>359-1142</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Taniwaki Masanori, Dr.</last_name>
      <phone>4 2940 8611</phone>
      <phone_ext>+81</phone_ext>
      <email>grand_wagoneer_797@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sapporo Higashi Tokushukai Hospital</name>
      <address>
        <city>Sapporo</city>
        <zip>065-0033</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuki Katagiri, Dr. med</last_name>
      <email>ykatagiri.ggl@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lorenz Räber, Prof MD</last_name>
      <phone>+41 31 632 09 29</phone>
      <email>lorenz.raeber@insel.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHUV</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephane Fournier, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Japan</country>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Makikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sorensen HT, Nielsen PH, Niemela M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Frobert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31. Erratum In: Lancet. 2016 Dec 3;388(10061):2742.</citation>
    <PMID>27810312</PMID>
  </reference>
  <reference>
    <citation>Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096.</citation>
    <PMID>30165437</PMID>
  </reference>
  <reference>
    <citation>Jasti V, Ivan E, Yalamanchili V, Wongpraparut N, Leesar MA. Correlations between fractional flow reserve and intravascular ultrasound in patients with an ambiguous left main coronary artery stenosis. Circulation. 2004 Nov 2;110(18):2831-6. doi: 10.1161/01.CIR.0000146338.62813.E7. Epub 2004 Oct 18.</citation>
    <PMID>15492302</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>Norgaard BL, Leipsic J, Gaur S, Seneviratne S, Ko BS, Ito H, Jensen JM, Mauri L, De Bruyne B, Bezerra H, Osawa K, Marwan M, Naber C, Erglis A, Park SJ, Christiansen EH, Kaltoft A, Lassen JF, Botker HE, Achenbach S; NXT Trial Study Group. Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). J Am Coll Cardiol. 2014 Apr 1;63(12):1145-1155. doi: 10.1016/j.jacc.2013.11.043. Epub 2014 Jan 30.</citation>
    <PMID>24486266</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary artery disease</keyword>
  <keyword>Fractional flow reserve</keyword>
  <keyword>Optical coherence tomography</keyword>
  <keyword>Computed tomography angiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03820492
org study id: OPTICO-LM
nct id: NCT03820492
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate
      judgement of the prognostic significance of LM stenosis is essential to improve patients'
      prognosis. Recently, fractional flow reserve (FFR) has become widespread practice and carries
      a Class Ia recommendation to assess functional significance of intermediate coronary stenosis
      in patients with stable angina. Intravascular ultrasound (IVUS)-derived minimum lumen area
      (MLA) represents an accurate measure to determine LM significance as shown in multiple
      studies, while optical coherence tomography (OCT) ,which is a novel intracoronary imaging
      method with a greater spatial resolution (15μm vs. 100μm), faster image acquisition and
      facilitated image interpretation, OCT derived-MLA has never been validated against FFR and
      accordingly, it is not mentioned in the current guidelines for myocardial revascularization.
      Coronary computed tomography angiography (CTA) has emerged as a noninvasive alternative of
      coronary angiography with its excellent negative predictive value, while the positive
      predictive value of CTA is limited. Computational fluid dynamics is an emerging method that
      enables prediction of blood flow in coronary arteries and calculation of FFR from computed
      tomography (FFRCT) noninvasively. Noninvasive and accurate assessment of functional
      significance would bring a great benefit for patients with LM stenosis, however, there are no
      data to evaluate the diagnostic accuracy of FFRCT for LM stenosis in comparison with FFR and
      minimal lumen area derived by OCT.

      This study will investigate the optimal OCT-derived MLA cut-off point and the diagnostic
      performance of FFRCT for intermediate LM stenosis compared with FFR ≤0.8 as a reference
      standard.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: OCT vs. FFR
time frame: Measurement at Procedure/ Baseline Visit
description: - The area under the curve of OCT-derived MLA for FFR≤0.8
measure: OCT vs. FFR
time frame: Measurement at Procedure/ Baseline Visit
description: -The optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.8
measure: FFRCT vs. FFR
time frame: Measurement at Procedure/ Baseline Visit
description: Diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of FFRCT≤0.8 for FFR≤0.8
measure: OCT vs. FFR, RFR, resting Pd/Pa, FFRCT, QFR
time frame: Measurement at Procedure/ Baseline Visit
description: - The area under the curve and the optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80
measure: OCT vs. FFR, RFR, resting Pd/Pa, FFRCT
time frame: Measurement at Procedure/ Baseline Visit
description: - Predictability of MLA, minimal lumen diameter, area stenosis, lesion length, eccentricity index, and plaque characteristics (plaque rupture, fibroatheroma, and calcification) for FFR ≤0.8, FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80
measure: OCT vs. FFR, RFR, resting Pd/Pa, FFRCT
time frame: Measurement at Procedure/ Baseline Visit
description: - Correlation among OCT-derived MLA, FFR, RFR, resting Pd/Pa, and FFRCT and QFR
measure: OCT vs. CTA
time frame: Measurement at Procedure/ Baseline Visit
description: - Correlation between luminal diameter stenosis of CTA and OCT-derived MLA
measure: OCT vs. CTA
time frame: Measurement at Procedure/ Baseline Visit
description: - Diagnostic accuracy of plaque characteristics with presumed high risk characteristics including napkin ring sign, low attenuation plaque (<30HU), positive remodelling (remodelling index >1.1), and spotty calcium (<3mm) for thin and thick cap fibroatheroma by OCT.
measure: Clinical endpoint at 1 year
time frame: 12 Month
description: Death
measure: Clinical endpoint at 1 year
time frame: 12 Month
description: Myocardial infarction
measure: Clinical endpoint at 1 year
time frame: 12 Month
description: Target vessel myocardial infarction
measure: Clinical endpoint at 1 year
time frame: 12 Month
description: Target lesion revascularization
measure: Clinical endpoint at 1 year
time frame: 12 Month
description: Target vessel revascularization
measure: Clinical endpoint at 1 year
time frame: 12 Month
description: Any revascularization
measure: Clinical endpoint at 1 year
time frame: 12 Month
description: Stent thrombosis
measure: Clinical endpoint at 1 year
time frame: 12 Month
description: Stroke and transient ischemic attack
measure: Clinical endpoint at 1 year
time frame: 12 Month
description: Acute renal failure
arm group label: Patient with left-main stenosis
arm group type: Other
description: Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT
intervention type: Diagnostic Test
intervention name: OCT, FFR, CTA and FFRCT
description: Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT
arm group label: Patient with left-main stenosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lorenz Raeber, Prof. MD PhD
role: Principal Investigator
affiliation: Inselspital
last name: Lorenz Raeber, Prof. MD PhD
phone: +41316322111
email: lorenz.raeber@insel.ch
last name: Hiroki Shinutani, MD
phone: +41316322111
email: hiroki.shibutani@extern.insel.ch
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status: Recruiting
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country: France
country: Germany
country: Japan
country: Switzerland
citation: Makikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sorensen HT, Nielsen PH, Niemela M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Frobert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31. Erratum In: Lancet. 2016 Dec 3;388(10061):2742.
PMID: 27810312
citation: Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096.
PMID: 30165437
citation: Jasti V, Ivan E, Yalamanchili V, Wongpraparut N, Leesar MA. Correlations between fractional flow reserve and intravascular ultrasound in patients with an ambiguous left main coronary artery stenosis. Circulation. 2004 Nov 2;110(18):2831-6. doi: 10.1161/01.CIR.0000146338.62813.E7. Epub 2004 Oct 18.
PMID: 15492302
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: Norgaard BL, Leipsic J, Gaur S, Seneviratne S, Ko BS, Ito H, Jensen JM, Mauri L, De Bruyne B, Bezerra H, Osawa K, Marwan M, Naber C, Erglis A, Park SJ, Christiansen EH, Kaltoft A, Lassen JF, Botker HE, Achenbach S; NXT Trial Study Group. Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). J Am Coll Cardiol. 2014 Apr 1;63(12):1145-1155. doi: 10.1016/j.jacc.2013.11.043. Epub 2014 Jan 30.
PMID: 24486266
responsible party type: Sponsor
mesh term: Coronary Stenosis
mesh term: Constriction, Pathologic
sharing ipd: No