<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/NCT02972489</url>
  </required_header>
  <id_info>
    <org_study_id>OPTI001</org_study_id>
    <nct_id>NCT02972489</nct_id>
  </id_info>
  <brief_title>Using 3D Imaging to Optimize Bifurcation Stenting</brief_title>
  <official_title>On-line 3-dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent: OPTIMUM Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Increase Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fujita Health University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Terumo Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Increase Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to determine whether bifurcation stenting guided by&#xD;
      on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that with&#xD;
      angiographic guidance by measuring incomplete stent apposition (ISA) in the bifurcation&#xD;
      segment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The recently developed optical frequency domain imaging (OFDI) can provide high quality&#xD;
      resolution images of the coronary arteries. This new imaging system enhances the&#xD;
      understanding of complex coronary lesions and the complex interaction between coronary&#xD;
      devices and vessels by assembling/compiling 2-dimensional cross sections.&#xD;
&#xD;
      This 3-dimensional reconstruction with strut segmentation becomes possible on-line in the&#xD;
      TERUMO OFDI console with 3-dimensional imaging software, which enables stent enhancement and&#xD;
      3D reconstruction within one minute. This &quot;real time&quot; 3D OFDI will promote the utilisation of&#xD;
      3-dimensional assessment in the treatment of bifurcation lesions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of malapposed struts</measure>
    <time_frame>at time of bifurcation PCI surgery</time_frame>
    <description>Percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of fulfilling optimal recrossing criteria on 3D-OFDI</measure>
    <time_frame>at time of bifurcation PCI surgery</time_frame>
    <description>Measured as a percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incomplete stent apposition (ISA) area (mm²)</measure>
    <time_frame>at time of bifurcation PCI surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum lumen area (mm²)</measure>
    <time_frame>at time of bifurcation PCI surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean lumen area (mm²)</measure>
    <time_frame>at time of bifurcation PCI surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum stent area (mm²)</measure>
    <time_frame>at time of bifurcation PCI surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean stent area (mm²)</measure>
    <time_frame>at time of bifurcation PCI surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean protrusion area (mm²)</measure>
    <time_frame>at time of bifurcation PCI surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum protrusion area (mm²)</measure>
    <time_frame>at time of bifurcation PCI surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum flow area (mm²)</measure>
    <time_frame>at time of bifurcation PCI surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean flow area (mm²)</measure>
    <time_frame>at time of bifurcation PCI surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">106</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Bifurcation Lesion</condition>
  <arm_group>
    <arm_group_label>3D OFDI guidance arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bifurcation percutaneous coronary intervention (PCI) optimized by online-3D OFDI during and after procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Angio guidance arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bifurcation percutaneous coronary intervention (PCI) guided by angiography</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D OFDI guidance arm</intervention_name>
    <description>Subjects randomized to 3D-guidance arm will undergo optical frequency domain imaging (OFDI) assessment in the main vessel after re-wiring into the jailed side branch following stent implantation. If the position of the wire is not located in the optimal cell, further attempts to redirect the wire to the optimal cell will be performed, with subsequent OFDI acquisitions to confirm position in 2D and off-line 3D reconstruction. After procedure, OFDI is performed in the main branch.</description>
    <arm_group_label>3D OFDI guidance arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Angio guidance arm</intervention_name>
    <description>In angiography-guidance group, wire recrossing into the side branch will be performed using conventional fluoroscopic/angiographic guidance. After finishing the procedure, OFDI is performed in the main branch but the results will be blinded to the operators.</description>
    <arm_group_label>Angio guidance arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is at least 18 years of age and signed Informed Consent&#xD;
&#xD;
          2. Subject has coronary artery disease involving a bifurcation with objective evidence of&#xD;
             ischemia including patients with chronic stable angina, silent ischemia and non-ST&#xD;
             segment elevation acute coronary syndrome (NSTE-ACS)&#xD;
&#xD;
          3. Subject is appropriate to be treated by PCI according to the local practice&#xD;
             (operator's judgment or heart team decision)&#xD;
&#xD;
          4. Patients' residence is in the area covered by the hospital&#xD;
&#xD;
          5. Patients with angiographically significant stenosis (&gt;50 % by visual assessment) in de&#xD;
             novo, native, previously unstented bifurcation lesion(s) including left main lesion,&#xD;
             which is in operator's opinion appropriate to be treated by PCI with a single stent&#xD;
             strategy&#xD;
&#xD;
          6. The size of main vessel matches available Ultimaster stent sizes (&lt;4.0 mm, and 2.0 mm&#xD;
             by visual assessment)&#xD;
&#xD;
          7. The size of side branch is &gt;2.0mm in diameter by visual assessment&#xD;
&#xD;
          8. The sidebranch is treatable with a sidebranch fenestration and/or kissing balloon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. Patients with ST elevation myocardial infarction&#xD;
&#xD;
          3. Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, sirolimus,&#xD;
             contrast material&#xD;
&#xD;
          4. Known thrombocytopenia (platelet count&lt; 100,000/mm3)&#xD;
&#xD;
          5. Cardiogenic Shock&#xD;
&#xD;
          6. Significant comorbidities precluding clinical follow-up (as judged by investigators)&#xD;
&#xD;
          7. Major planned surgery that requires discontinuation of dual antiplatelet therapy&#xD;
&#xD;
          8. History of stenting in the target bifurcation lesion&#xD;
&#xD;
          9. Renal insufficiency (GFR/MDRD &lt;45 ml/min), which precludes in operator's opinion&#xD;
             contrast injection during repeat OFDI pullback&#xD;
&#xD;
         10. Severely tortuous or angulated coronary anatomy of the study vessel that in the&#xD;
             opinion of the investigator would result in sub-optimal optical frequency domain&#xD;
             imaging (OFDI) or excessive risk of complication to place an OFDI catheter&#xD;
&#xD;
         11. Target lesion reference vessel diameter (RVD) &lt; 2.25 and &gt; 4 mm&#xD;
&#xD;
         12. Other: Patient is judged inappropriate by the attending physician&#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>Yoshinobu Onuma</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fujita Health University/Erasmus University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yoshinobu Onuma</last_name>
    <phone>(011)+31-10-704-0704</phone>
    <email>yoshinobuonuma@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fujita Health University</name>
      <address>
        <city>Toyoake</city>
        <state>Aichi Prefecture</state>
        <zip>470-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus University Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <state>South Holland</state>
        <zip>3015 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Lassen JF, Holm NR, Stankovic G, Lefevre T, Chieffo A, Hildick-Smith D, Pan M, Darremont O, Albiero R, Ferenc M, Louvard Y. Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings. EuroIntervention. 2014 Sep;10(5):545-60. doi: 10.4244/EIJV10I5A97.</citation>
    <PMID>25256198</PMID>
  </reference>
  <reference>
    <citation>Foin N, Torii R, Alegria E, Sen S, Petraco R, Nijjer S, Ghione M, Davies JE, Di Mario C. Location of side branch access critically affects results in bifurcation stenting: Insights from bench modeling and computational flow simulation. Int J Cardiol. 2013 Oct 9;168(4):3623-8. doi: 10.1016/j.ijcard.2013.05.036. Epub 2013 May 25.</citation>
    <PMID>23714592</PMID>
  </reference>
  <reference>
    <citation>Alegria-Barrero E, Foin N, Chan PH, Syrseloudis D, Lindsay AC, Dimopolous K, Alonso-Gonzalez R, Viceconte N, De Silva R, Di Mario C. Optical coherence tomography for guidance of distal cell recrossing in bifurcation stenting: choosing the right cell matters. EuroIntervention. 2012 Jun 20;8(2):205-13. doi: 10.4244/EIJV8I2A34.</citation>
    <PMID>22581489</PMID>
  </reference>
  <reference>
    <citation>Okamura T, Onuma Y, Garcia-Garcia HM, Bruining N, Serruys PW. High-speed intracoronary optical frequency domain imaging: implications for three-dimensional reconstruction and quantitative analysis. EuroIntervention. 2012 Feb;7(10):1216-26. doi: 10.4244/EIJV7I10A194.</citation>
    <PMID>22334321</PMID>
  </reference>
  <reference>
    <citation>Okamura T, Onuma Y, Yamada J, Iqbal J, Tateishi H, Nao T, Oda T, Maeda T, Nakamura T, Miura T, Yano M, Serruys PW. 3D optical coherence tomography: new insights into the process of optimal rewiring of side branches during bifurcational stenting. EuroIntervention. 2014 Dec;10(8):907-15. doi: 10.4244/EIJV10I8A157.</citation>
    <PMID>24531393</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT02972489
org study id: OPTI001
nct id: NCT02972489
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The primary purpose of this study is to determine whether bifurcation stenting guided by
      on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that with
      angiographic guidance by measuring incomplete stent apposition (ISA) in the bifurcation
      segment.
The recently developed optical frequency domain imaging (OFDI) can provide high quality
      resolution images of the coronary arteries. This new imaging system enhances the
      understanding of complex coronary lesions and the complex interaction between coronary
      devices and vessels by assembling/compiling 2-dimensional cross sections.

      This 3-dimensional reconstruction with strut segmentation becomes possible on-line in the
      TERUMO OFDI console with 3-dimensional imaging software, which enables stent enhancement and
      3D reconstruction within one minute. This "real time" 3D OFDI will promote the utilisation of
      3-dimensional assessment in the treatment of bifurcation lesions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of malapposed struts
time frame: at time of bifurcation PCI surgery
description: Percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel
measure: Incidence of fulfilling optimal recrossing criteria on 3D-OFDI
time frame: at time of bifurcation PCI surgery
description: Measured as a percentage
measure: Incomplete stent apposition (ISA) area (mm²)
time frame: at time of bifurcation PCI surgery
measure: Minimum lumen area (mm²)
time frame: at time of bifurcation PCI surgery
measure: Mean lumen area (mm²)
time frame: at time of bifurcation PCI surgery
measure: Minimum stent area (mm²)
time frame: at time of bifurcation PCI surgery
measure: Mean stent area (mm²)
time frame: at time of bifurcation PCI surgery
measure: Mean protrusion area (mm²)
time frame: at time of bifurcation PCI surgery
measure: Maximum protrusion area (mm²)
time frame: at time of bifurcation PCI surgery
measure: Minimum flow area (mm²)
time frame: at time of bifurcation PCI surgery
measure: Mean flow area (mm²)
time frame: at time of bifurcation PCI surgery
arm group label: 3D OFDI guidance arm
arm group type: Experimental
description: Bifurcation percutaneous coronary intervention (PCI) optimized by online-3D OFDI during and after procedure
arm group label: Angio guidance arm
arm group type: Active Comparator
description: Bifurcation percutaneous coronary intervention (PCI) guided by angiography
intervention type: Device
intervention name: 3D OFDI guidance arm
description: Subjects randomized to 3D-guidance arm will undergo optical frequency domain imaging (OFDI) assessment in the main vessel after re-wiring into the jailed side branch following stent implantation. If the position of the wire is not located in the optimal cell, further attempts to redirect the wire to the optimal cell will be performed, with subsequent OFDI acquisitions to confirm position in 2D and off-line 3D reconstruction. After procedure, OFDI is performed in the main branch.
arm group label: 3D OFDI guidance arm
intervention type: Device
intervention name: Angio guidance arm
description: In angiography-guidance group, wire recrossing into the side branch will be performed using conventional fluoroscopic/angiographic guidance. After finishing the procedure, OFDI is performed in the main branch but the results will be blinded to the operators.
arm group label: Angio guidance arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yoshinobu Onuma
role: Principal Investigator
affiliation: Fujita Health University/Erasmus University Medical Center
last name: Yoshinobu Onuma
phone: (011)+31-10-704-0704
email: yoshinobuonuma@gmail.com
facility: 
facility: 
country: Japan
country: Netherlands
citation: Lassen JF, Holm NR, Stankovic G, Lefevre T, Chieffo A, Hildick-Smith D, Pan M, Darremont O, Albiero R, Ferenc M, Louvard Y. Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings. EuroIntervention. 2014 Sep;10(5):545-60. doi: 10.4244/EIJV10I5A97.
PMID: 25256198
citation: Foin N, Torii R, Alegria E, Sen S, Petraco R, Nijjer S, Ghione M, Davies JE, Di Mario C. Location of side branch access critically affects results in bifurcation stenting: Insights from bench modeling and computational flow simulation. Int J Cardiol. 2013 Oct 9;168(4):3623-8. doi: 10.1016/j.ijcard.2013.05.036. Epub 2013 May 25.
PMID: 23714592
citation: Alegria-Barrero E, Foin N, Chan PH, Syrseloudis D, Lindsay AC, Dimopolous K, Alonso-Gonzalez R, Viceconte N, De Silva R, Di Mario C. Optical coherence tomography for guidance of distal cell recrossing in bifurcation stenting: choosing the right cell matters. EuroIntervention. 2012 Jun 20;8(2):205-13. doi: 10.4244/EIJV8I2A34.
PMID: 22581489
citation: Okamura T, Onuma Y, Garcia-Garcia HM, Bruining N, Serruys PW. High-speed intracoronary optical frequency domain imaging: implications for three-dimensional reconstruction and quantitative analysis. EuroIntervention. 2012 Feb;7(10):1216-26. doi: 10.4244/EIJV7I10A194.
PMID: 22334321
citation: Okamura T, Onuma Y, Yamada J, Iqbal J, Tateishi H, Nao T, Oda T, Maeda T, Nakamura T, Miura T, Yano M, Serruys PW. 3D optical coherence tomography: new insights into the process of optimal rewiring of side branches during bifurcational stenting. EuroIntervention. 2014 Dec;10(8):907-15. doi: 10.4244/EIJV10I8A157.
PMID: 24531393
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: No