<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/NCT03292081</url>
  </required_header>
  <id_info>
    <org_study_id>14-106</org_study_id>
    <nct_id>NCT03292081</nct_id>
  </id_info>
  <brief_title>Comparison Between OFDI and IVUS in PCI Guidance for Biolimus A9 Eluting Stent Implantation</brief_title>
  <acronym>MISTIC-1</acronym>
  <official_title>Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound in Percutaneous Coronary Intervention Guidance for Biolimus A9 Eluting Stent Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujita Health University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujita Health University</source>
  <oversight_info>
    <has_dmc>No</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>
      The aim of this study is to assess clinical safety and efficacy of percutaneous coronary&#xD;
      intervention (PCI) using a newer generation drug-eluting stent (DES) in the context of&#xD;
      optical frequency domain imaging (OFDI) guidance or intravascular ultrasound (IVUS) guidance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intracoronary imaging techniques provide clinically useful information in the setting of PCI,&#xD;
      such as lesion severity, tissue characterization, vessel sizing, and stent optimization.&#xD;
      Current evidences suggest potential advantage of intracoronary imaging guidance in reducing&#xD;
      the risk of major adverse cardiac events after stent implantation over conventional PCI under&#xD;
      angiographic guidance alone. IVUS has been clinically used in two decades and it is known as&#xD;
      one of the most dominant intracoronary imaging technique. OFDI is a new light-based&#xD;
      intracoronary imaging technology which provides higher image resolution and higher-speed&#xD;
      pullback compared to those of IVUS. Given the different properties between ultrasound-based&#xD;
      IVUS and light-based OFDI, treatment and clinical impact of these two imaging techniques&#xD;
      would be different.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 12, 2014</start_date>
  <completion_date type="Anticipated">October 25, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2016</primary_completion_date>
  <phase>Phase 2</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Minimum lumen area assessed by OFDI</measure>
    <time_frame>8 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular mortality</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel myocardial infarction</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion revascularization</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apposition of stent struts assessed by OFDI</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue coverage of stent struts assessed by OFDI</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative Coronary Angiography (QCA)</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Integrated Backscatter IVUS (IB-IVUS)</measure>
    <time_frame>0 month (pre-procedure)</time_frame>
    <description>Plaque components including lipid pool, fibrosis, dense fibrosis or calcification</description>
  </other_outcome>
  <other_outcome>
    <measure>Detectable external elastic lamina (EEL) arc assessed by OFDI</measure>
    <time_frame>0 month (pre-procedure)</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>OFDI-guided PCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>IVUS-guided PCI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OFDI</intervention_name>
    <description>PCI under OFDI guidance</description>
    <arm_group_label>OFDI-guided PCI</arm_group_label>
    <other_name>LUNAWAVE imaging console</other_name>
    <other_name>Fastview imaging catheter</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IVUS</intervention_name>
    <description>PCI under IVUS guidance</description>
    <arm_group_label>IVUS-guided PCI</arm_group_label>
    <other_name>VISIWAVE imaging console</other_name>
    <other_name>ViewIT imaging catheter</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with stable coronary artery disease who have symptoms or myocardial ischemia&#xD;
             proven by non-invasive or invasive stress test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Renal insufficiency with estimated glomerular filtration rate (eGFR) &lt;45 mL/min/1.73m2&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) &lt;30% or history of congestive heart failure&#xD;
&#xD;
          -  Acute coronary syndrome within 7 days after onset&#xD;
&#xD;
          -  Considered as inappropriate for drug-eluting stent (DES) use or dual antiplatelet&#xD;
             therapy for one year after the index procedure&#xD;
&#xD;
          -  Life expectancy within one year&#xD;
&#xD;
          -  Lesion length estimated by quantitative coronary angiography (QCA) &gt;28mm&#xD;
&#xD;
          -  Chronic total occlusion&#xD;
&#xD;
          -  Left main stem lesion&#xD;
&#xD;
          -  Bifurcation requiring side branch balloon dilatation&#xD;
&#xD;
          -  Severely calcified lesion&#xD;
&#xD;
          -  Other conditions by which physicians in charge judged inappropriate to enroll the&#xD;
             patients because of safety concern.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fujita Health University</name>
      <address>
        <city>Toyoake</city>
        <zip>470-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 22, 2017</last_update_submitted>
  <last_update_submitted_qc>September 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fujita Health University</investigator_affiliation>
    <investigator_full_name>Yukio Ozaki</investigator_full_name>
    <investigator_title>Professor, Department of Cardiology</investigator_title>
  </responsible_party>
  <keyword>Intracoronary Imaging</keyword>
  <keyword>Optical Frequency Domain Imaging</keyword>
  <keyword>Intravascular Ultrasound</keyword>
  <keyword>Percutaneous Coronary Intervention</keyword>
  <keyword>Drug Eluting Stent</keyword>
  <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>Undecided</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/NCT03292081
org study id: 14-106
nct id: NCT03292081
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess clinical safety and efficacy of percutaneous coronary
      intervention (PCI) using a newer generation drug-eluting stent (DES) in the context of
      optical frequency domain imaging (OFDI) guidance or intravascular ultrasound (IVUS) guidance.
Intracoronary imaging techniques provide clinically useful information in the setting of PCI,
      such as lesion severity, tissue characterization, vessel sizing, and stent optimization.
      Current evidences suggest potential advantage of intracoronary imaging guidance in reducing
      the risk of major adverse cardiac events after stent implantation over conventional PCI under
      angiographic guidance alone. IVUS has been clinically used in two decades and it is known as
      one of the most dominant intracoronary imaging technique. OFDI is a new light-based
      intracoronary imaging technology which provides higher image resolution and higher-speed
      pullback compared to those of IVUS. Given the different properties between ultrasound-based
      IVUS and light-based OFDI, treatment and clinical impact of these two imaging techniques
      would be different.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Minimum lumen area assessed by OFDI
time frame: 8 months
measure: Cardiovascular mortality
time frame: 8 months
measure: Target vessel myocardial infarction
time frame: 8 months
measure: Target lesion revascularization
time frame: 8 months
measure: Apposition of stent struts assessed by OFDI
time frame: 8 months
measure: Tissue coverage of stent struts assessed by OFDI
time frame: 8 months
measure: Quantitative Coronary Angiography (QCA)
time frame: 8 months
measure: Integrated Backscatter IVUS (IB-IVUS)
time frame: 0 month (pre-procedure)
description: Plaque components including lipid pool, fibrosis, dense fibrosis or calcification
measure: Detectable external elastic lamina (EEL) arc assessed by OFDI
time frame: 0 month (pre-procedure)
arm group label: OFDI-guided PCI
arm group type: Experimental
arm group label: IVUS-guided PCI
arm group type: Active Comparator
intervention type: Device
intervention name: OFDI
description: PCI under OFDI guidance
arm group label: OFDI-guided PCI
other name: LUNAWAVE imaging console
other name: Fastview imaging catheter
intervention type: Device
intervention name: IVUS
description: PCI under IVUS guidance
arm group label: IVUS-guided PCI
other name: VISIWAVE imaging console
other name: ViewIT imaging catheter
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Fujita Health University
investigator full name: Yukio Ozaki
investigator title: Professor, Department of Cardiology
mesh term: Coronary Artery Disease
sharing ipd: Undecided