<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/NCT02984891</url>
  </required_header>
  <id_info>
    <org_study_id>AAAQ8295</org_study_id>
    <nct_id>NCT02984891</nct_id>
  </id_info>
  <brief_title>Optical Coherence Tomography (OCT) Intravascular Ultrasound (IVUS) Dual Imaging</brief_title>
  <official_title>Dual Imaging Using High-definition Intravascular Ultrasound and Optical Coherence Tomography to Guide Percutaneous Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are standardly&#xD;
      used and have been extensively studied separately to guide percutaneous coronary intervention&#xD;
      and improve long-term outcomes. In this study, the investigators aim to directly compare&#xD;
      high-definition IVUS images to OCT in the same patients to determine the differences between&#xD;
      each modality as they relate to imaging coronary pathology, with the goal of determining&#xD;
      which modality is most appropriate in particular clinical scenarios.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intravascular ultrasound (IVUS) is an imaging modality that uses ultrasound waves to allow&#xD;
      for detailed evaluation of coronary atherosclerotic plaques and the vascular response to&#xD;
      coronary interventional devices to guide stent placement during percutaneous coronary&#xD;
      intervention. Current conventional IVUS catheters emit ultrasound waves ranging from 20-40&#xD;
      megahertz (mHz), and more recently released high-definition IVUS catheters emit sound waves&#xD;
      at 60 mHz, allowing for better image quality, quantitative accuracy, and precision in&#xD;
      measurements.&#xD;
&#xD;
      Optical coherence tomography (OCT) is an alternative imaging modality used for similar&#xD;
      purposes as IVUS, using a single optical fiber that emits infrared light to image the&#xD;
      coronary artery. OCT uses light in the infrared spectrum with a central wavelength between&#xD;
      1,250 and 1,350 nm. Axial resolution with OCT is 10-20 microns, whereas it is typically&#xD;
      100-200 microns with IVUS. Thus, OCT allows for better image resolution, but this comes at&#xD;
      the expense of tissue penetration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">October 6, 2016</start_date>
  <completion_date type="Actual">June 27, 2018</completion_date>
  <primary_completion_date type="Actual">June 27, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Lumen area</measure>
    <time_frame>Up to 1 hour</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Luminal diameter</measure>
    <time_frame>Up to 1 hour</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">7</enrollment>
  <condition>Coronary Artery Disease (CAD)</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <description>Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) will be used in patients with coronary artery disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Optical Coherence Tomography (OCT)</intervention_name>
    <description>Procedure will be performed using the OCT Dragonfly catheter is a hydrophilic-coated catheter that uses infrared light with a central wavelength between 1,250 and 1,350 nm. Axial resolution with OCT is 10-20 microns, and maximum tissue penetration with OCT is approximately 1.5 mm-3 mm.</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>OCT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intravascular Ultrasound (IVUS)</intervention_name>
    <description>Procedure will be performed using the IVUS Kodama catheter is a hydrophilic-coated catheter that used high-fidelity ultrasound transmission to capture high-definition images of coronary artery anatomy. It uses ultrasound waves with a frequency of 40 or 60 MHz, as opposed to 20 MHz in conventional IVUS, to improve resolution while optimizing tissue penetration. It provides axial resolution of &lt; 40 microns and tissue penetration of 10 mm.</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>IVUS</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients included in the study will be those with coronary artery disease who are scheduled&#xD;
        to undergo standard angiography in the cardiac catheterization lab.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Undergone diagnostic coronary angiography&#xD;
&#xD;
          -  Evidence of coronary pathology that requires further imaging to guide treatment&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Significant renal insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ziad A. Ali, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intravascular ultrasound</keyword>
  <keyword>Optical coherence tomography</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>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/NCT02984891
org study id: AAAQ8295
nct id: NCT02984891
lead sponsor: 
has dmc: No
Both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are standardly
      used and have been extensively studied separately to guide percutaneous coronary intervention
      and improve long-term outcomes. In this study, the investigators aim to directly compare
      high-definition IVUS images to OCT in the same patients to determine the differences between
      each modality as they relate to imaging coronary pathology, with the goal of determining
      which modality is most appropriate in particular clinical scenarios.
Intravascular ultrasound (IVUS) is an imaging modality that uses ultrasound waves to allow
      for detailed evaluation of coronary atherosclerotic plaques and the vascular response to
      coronary interventional devices to guide stent placement during percutaneous coronary
      intervention. Current conventional IVUS catheters emit ultrasound waves ranging from 20-40
      megahertz (mHz), and more recently released high-definition IVUS catheters emit sound waves
      at 60 mHz, allowing for better image quality, quantitative accuracy, and precision in
      measurements.

      Optical coherence tomography (OCT) is an alternative imaging modality used for similar
      purposes as IVUS, using a single optical fiber that emits infrared light to image the
      coronary artery. OCT uses light in the infrared spectrum with a central wavelength between
      1,250 and 1,350 nm. Axial resolution with OCT is 10-20 microns, whereas it is typically
      100-200 microns with IVUS. Thus, OCT allows for better image resolution, but this comes at
      the expense of tissue penetration.
observational model: Cohort
time perspective: Prospective
measure: Lumen area
time frame: Up to 1 hour
measure: Luminal diameter
time frame: Up to 1 hour
arm group label: Treatment
description: Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) will be used in patients with coronary artery disease.
intervention type: Procedure
intervention name: Optical Coherence Tomography (OCT)
description: Procedure will be performed using the OCT Dragonfly catheter is a hydrophilic-coated catheter that uses infrared light with a central wavelength between 1,250 and 1,350 nm. Axial resolution with OCT is 10-20 microns, and maximum tissue penetration with OCT is approximately 1.5 mm-3 mm.
arm group label: Treatment
other name: OCT
intervention type: Procedure
intervention name: Intravascular Ultrasound (IVUS)
description: Procedure will be performed using the IVUS Kodama catheter is a hydrophilic-coated catheter that used high-fidelity ultrasound transmission to capture high-definition images of coronary artery anatomy. It uses ultrasound waves with a frequency of 40 or 60 MHz, as opposed to 20 MHz in conventional IVUS, to improve resolution while optimizing tissue penetration. It provides axial resolution of < 40 microns and tissue penetration of 10 mm.
arm group label: Treatment
other name: IVUS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ziad A. Ali, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: No