<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/NCT02237456</url>
  </required_header>
  <id_info>
    <org_study_id>1-10-72-59-14</org_study_id>
    <nct_id>NCT02237456</nct_id>
  </id_info>
  <brief_title>DOCTOR Compare - A Study in the &quot;DOCTOR&quot; Series (Does Optical Coherence Tomography Optimize Revascularization?&quot;</brief_title>
  <official_title>Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Metallic Stents and Bioresorbable Vascular Scaffolds - DOCTOR Compare</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital Skejby</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aarhus University Hospital Skejby</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare optical coherence tomography (OCT) scans performed in&#xD;
      the same coronary artery with two different OCT systems (Lunawave and OPTIS) before and after&#xD;
      implantation of stents or bioresorbable scaffolds.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Standard treatment of persons with narrowings of the heart's coronary artery is balloon&#xD;
      treatment with implantation of stents (Percutaneous coronary intervention (PCI )). To&#xD;
      evaluate disease in coronary arteries prior to, and during PCI , X-ray fluoroscopy with&#xD;
      contrast is used. X-ray fluoroscopy produces little information of any disease changes in the&#xD;
      vessel wall and implanted stents and especially polylactid acid (PLA) type bioresorbable&#xD;
      scaffolds are visualized poorly .&#xD;
&#xD;
      Optical coherence tomography (OCT) is a light-based, high resolution, imaging modality for&#xD;
      intra coronary assessment of tissue and implants. Currently two CE-marked OCT systems are&#xD;
      used in clinical practice in (Illumien OPTIS, St. Jude Medical , Minnesota, USA and Lunawave,&#xD;
      Terumo , Tokyo, Japan). It is a common assumption that the scanning images for the two&#xD;
      systems are similar and are interpreted the same way.&#xD;
&#xD;
      The aim of the study is to assess if tissue, stents and PLA type scaffolds are presented with&#xD;
      same characteristics by the two systems.&#xD;
&#xD;
      Same segment scans by the two systems will be systematically compared and reported.&#xD;
&#xD;
      Differences in scans by the two systems may have implications for the interpretation and thus&#xD;
      may affect clinical decisions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Comparison of quantitative and semi-quantitative tissue analysis obtained with OCT images</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristics of thrombic mass (average thickness of signal-rich area, shade degree)</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristics of fibrous tissue (maximum scan penetrance)</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristics of lipid plaque (signal intensities under the fibrous cap)</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristics of calcium plaque (matched calcium plaques that can be quantified for sizes)</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristics of vessel dissection (exploratory)</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristics of the fibrous cap (minimum thickness)</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detection of stent struts</measure>
    <time_frame>Baseline</time_frame>
    <description>Stent evaluation obtained by Lunawawe recordings versus OPTIS recordings (including areas with thrombus, plaque, bare metal stent, bioresorbable stents, 3D reconstruction of stents (qualitative and quantitative assessment of stent visualization degree)</description>
  </secondary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Coronary Disease</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Atherosclerosis</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Comparison of OCT scans</intervention_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients undergoing percutaneous coronary intervention (PCI) at Department of&#xD;
        Cardiology, Aarhus University Hospital Skejby, will be invited to participate in the study.&#xD;
        12 patients will be included; 4 with acute ST-elevation myocardial infarct (STEMI) and 8&#xD;
        stable or stabilized patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for intervention with PCI on the right or left coronary artery&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Must be able to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Expected life span of less than one year&#xD;
&#xD;
          -  Pregnancy or possible pregnancy&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Especially tortuous vessels&#xD;
&#xD;
          -  Renal impairment (creatinine&gt; 100 micromoles / L)&#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>Niels R Holm, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus N, Denmark</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>March 12, 2015</last_update_submitted>
  <last_update_submitted_qc>March 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital Skejby</investigator_affiliation>
    <investigator_full_name>Niels Ramsing Holm</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Myocardial infarction</keyword>
  <keyword>Atherosclerosis</keyword>
  <keyword>PCI</keyword>
  <keyword>OCT</keyword>
  <keyword>Optical coherence tomography</keyword>
  <keyword>Stent</keyword>
  <keyword>Bioresorbable stents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Infarction</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/NCT02237456
org study id: 1-10-72-59-14
nct id: NCT02237456
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare optical coherence tomography (OCT) scans performed in
      the same coronary artery with two different OCT systems (Lunawave and OPTIS) before and after
      implantation of stents or bioresorbable scaffolds.
Standard treatment of persons with narrowings of the heart's coronary artery is balloon
      treatment with implantation of stents (Percutaneous coronary intervention (PCI )). To
      evaluate disease in coronary arteries prior to, and during PCI , X-ray fluoroscopy with
      contrast is used. X-ray fluoroscopy produces little information of any disease changes in the
      vessel wall and implanted stents and especially polylactid acid (PLA) type bioresorbable
      scaffolds are visualized poorly .

      Optical coherence tomography (OCT) is a light-based, high resolution, imaging modality for
      intra coronary assessment of tissue and implants. Currently two CE-marked OCT systems are
      used in clinical practice in (Illumien OPTIS, St. Jude Medical , Minnesota, USA and Lunawave,
      Terumo , Tokyo, Japan). It is a common assumption that the scanning images for the two
      systems are similar and are interpreted the same way.

      The aim of the study is to assess if tissue, stents and PLA type scaffolds are presented with
      same characteristics by the two systems.

      Same segment scans by the two systems will be systematically compared and reported.

      Differences in scans by the two systems may have implications for the interpretation and thus
      may affect clinical decisions.
observational model: Cohort
time perspective: Prospective
measure: Comparison of quantitative and semi-quantitative tissue analysis obtained with OCT images
time frame: Baseline
measure: Characteristics of thrombic mass (average thickness of signal-rich area, shade degree)
time frame: Baseline
measure: Characteristics of fibrous tissue (maximum scan penetrance)
time frame: Baseline
measure: Characteristics of lipid plaque (signal intensities under the fibrous cap)
time frame: Baseline
measure: Characteristics of calcium plaque (matched calcium plaques that can be quantified for sizes)
time frame: Baseline
measure: Characteristics of vessel dissection (exploratory)
time frame: Baseline
measure: Characteristics of the fibrous cap (minimum thickness)
time frame: Baseline
measure: Detection of stent struts
time frame: Baseline
description: Stent evaluation obtained by Lunawawe recordings versus OPTIS recordings (including areas with thrombus, plaque, bare metal stent, bioresorbable stents, 3D reconstruction of stents (qualitative and quantitative assessment of stent visualization degree)
intervention type: Procedure
intervention name: Comparison of OCT scans
intervention type: Procedure
intervention name: Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Niels R Holm, MD
role: Principal Investigator
affiliation: Aarhus University Hospital
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital Skejby
investigator full name: Niels Ramsing Holm
investigator title: Doctor
mesh term: Myocardial Infarction
mesh term: Atherosclerosis
mesh term: Coronary Disease
mesh term: Infarction