<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/NCT02234804</url>
  </required_header>
  <id_info>
    <org_study_id>1-10-72-111-13</org_study_id>
    <nct_id>NCT02234804</nct_id>
  </id_info>
  <brief_title>The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study</brief_title>
  <acronym>DOCTOR Recross</acronym>
  <official_title>The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital Skejby</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Aarhus University Hospital Skejby</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, controlled, double randomized, non-blinded, multicenter, investigator initiated,&#xD;
      academic superiority trial comparing optical coherence tomography (OCT) guided vs.&#xD;
      angiography guided wire recrossing in jailed side branches (SB) (1. randomization&#xD;
      1:1)(superiority) and comparing Medtronic Resolute Integrity and Xience Prime for stent strut&#xD;
      apposition in the SB ostium (2. randomization 1:1) (superiority). Acute primary endpoint and&#xD;
      30 days clinical follow-up.&#xD;
&#xD;
      Hypothesis: OCT guided wire recrossing in bifurcation stenting results in less malapposed&#xD;
      struts in the segment facing the SB ostium.&#xD;
&#xD;
      Secondary hypothesis: Treatment by Medtronic Resolute Integrity stent results in less&#xD;
      malapposed struts at the bifurcation segment compared to treatment by the Abbott Xience Prime&#xD;
      stent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      To assess the ability of OCT to guide wire recrossing and reduce stent strut malapposition&#xD;
      after kissing balloon dilatation.&#xD;
&#xD;
      To compare stent strut apposition after treatment by two different stent designs using both&#xD;
      guiding strategies of wire recrossing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>N/A</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>Cross sectional stent strut malapposition in the main vessel bifurcation segment facing the side-branch ostium compared for optical coherence tomography and angioguided recrossing strategy</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedural: 1. Success in recrossing into designated strut hole when visible and indicated</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels)</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural: 3. Contrast use</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural: 4. Fluoroscopy time</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoints: 5. Malapposition in the main vessel segment limited by and facing the side-branch ostium compared for stent type (second randomization)</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoints: Malapposition in the proximal and distal main vessel segments and in the quadrants opposite to the side branch origin for stent type and recross strategy</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoints: Distance between malapposed strut and vessel wall in all segments for stent type and recross strategy</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoints: Minimum expansion of the stents expressed as absolute area and percentage of the closest reference area, for stent type and recross strategy</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoints: Ostial stent area stenosis by optical coherence tomography (side branch reference area by 3D QCA)</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoints: Segmental assessment; Proximal edge, proximal main vessel, bifurcation segment, distal main vessel, distal edge, ostial 5 mm of side branch. Pre and post side branch intervention</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ostial side branch area stenosis</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ostial side branch acute gain after main vessel (MV) stenting</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimal luminal area of all segments</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic area stenosis of all other segments</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Coronary Disease</condition>
  <arm_group>
    <arm_group_label>Medtronic Resolute Integrity stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OCT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Angiography</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Angiography to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xience Prime stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Xience Prime Stent</intervention_name>
    <arm_group_label>Angiography</arm_group_label>
    <arm_group_label>OCT</arm_group_label>
    <other_name>Stent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medtronic Resolute Integrity stent</intervention_name>
    <arm_group_label>Angiography</arm_group_label>
    <arm_group_label>OCT</arm_group_label>
    <other_name>Stent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Angiography</intervention_name>
    <arm_group_label>Medtronic Resolute Integrity stent</arm_group_label>
    <arm_group_label>Xience Prime stent</arm_group_label>
    <other_name>CAG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>OCT</intervention_name>
    <arm_group_label>Medtronic Resolute Integrity stent</arm_group_label>
    <arm_group_label>Xience Prime stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable or unstable angina pectoris or silent angina pectoris.&#xD;
&#xD;
          -  De novo coronary bifurcation lesions at &quot;LAD/diagonal&quot;, &quot;Cx/obtuse marginal&quot;, &quot;right&#xD;
             coronary artery (RCA)- posterior descending artery (PDA)/posterolateral branch&quot; or&#xD;
             &quot;left main (LM)/Cx/LAD&quot;.&#xD;
&#xD;
          -  All Medina classes except Medina 0.0.1.&#xD;
&#xD;
          -  Diameter of side branch ≥2.5 mm.&#xD;
&#xD;
          -  Diameter stenosis &gt;50% by operator's visual assessment&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ST-elevation infarction within 48 hours.&#xD;
&#xD;
          -  Side branch lesion length &gt;5 mm.&#xD;
&#xD;
          -  Expected survival &lt; 1 year&#xD;
&#xD;
          -  Severe heart failure (NYHA≥III)&#xD;
&#xD;
          -  S-creatinine &gt;120 µmol/l.&#xD;
&#xD;
          -  Allergy to Contrast media, Aspirin, Clopidogrel, Ticagrelor, Ticlopidine, Everolimus&#xD;
             or Zotarolimus.&#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 Skejby</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Niels R Holm, MD</last_name>
    <phone>+45 7845 0000</phone>
    <phone_ext>52254</phone_ext>
    <email>niels.holm@ki.au.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Evald H Christiansen, MD</last_name>
    <phone>+45 7845 0000</phone>
    <phone_ext>52028</phone_ext>
    <email>hellbarg@rm.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospitals Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tom Adriaenssens, MD</last_name>
    </contact>
    <investigator>
      <last_name>Tom Adriasenssens, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hspital</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Niels R Holm, MD</last_name>
      <phone>+45 7845 0000</phone>
      <phone_ext>52254</phone_ext>
      <email>niels.holm@clin.au.dk</email>
    </contact>
    <contact_backup>
      <last_name>Evald H Christiansen, MD</last_name>
      <phone>+45 7845 0000</phone>
      <phone_ext>52028</phone_ext>
      <email>hellbarg@rm.dk</email>
    </contact_backup>
    <investigator>
      <last_name>Niels R Holm, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Brompton Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlo DiMario, MD</last_name>
    </contact>
    <investigator>
      <last_name>Carlo DiMario, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Denmark</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>June 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>October 5, 2015</last_update_submitted>
  <last_update_submitted_qc>October 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 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>MD</investigator_title>
  </responsible_party>
  <keyword>Coronary angiography (CAG)</keyword>
  <keyword>Percutaneous coronary intervention (PCI)</keyword>
  <keyword>OCT</keyword>
  <keyword>Stent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Disease</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/NCT02234804
org study id: 1-10-72-111-13
nct id: NCT02234804
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Prospective, controlled, double randomized, non-blinded, multicenter, investigator initiated,
      academic superiority trial comparing optical coherence tomography (OCT) guided vs.
      angiography guided wire recrossing in jailed side branches (SB) (1. randomization
      1:1)(superiority) and comparing Medtronic Resolute Integrity and Xience Prime for stent strut
      apposition in the SB ostium (2. randomization 1:1) (superiority). Acute primary endpoint and
      30 days clinical follow-up.

      Hypothesis: OCT guided wire recrossing in bifurcation stenting results in less malapposed
      struts in the segment facing the SB ostium.

      Secondary hypothesis: Treatment by Medtronic Resolute Integrity stent results in less
      malapposed struts at the bifurcation segment compared to treatment by the Abbott Xience Prime
      stent.
Purpose:

      To assess the ability of OCT to guide wire recrossing and reduce stent strut malapposition
      after kissing balloon dilatation.

      To compare stent strut apposition after treatment by two different stent designs using both
      guiding strategies of wire recrossing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cross sectional stent strut malapposition in the main vessel bifurcation segment facing the side-branch ostium compared for optical coherence tomography and angioguided recrossing strategy
time frame: Baseline
measure: Procedural: 1. Success in recrossing into designated strut hole when visible and indicated
time frame: Baseline
measure: Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels)
time frame: Baseline
measure: Procedural: 3. Contrast use
time frame: Baseline
measure: Procedural: 4. Fluoroscopy time
time frame: Baseline
measure: Optical coherence tomography endpoints: 5. Malapposition in the main vessel segment limited by and facing the side-branch ostium compared for stent type (second randomization)
time frame: Baseline
measure: Optical coherence tomography endpoints: Malapposition in the proximal and distal main vessel segments and in the quadrants opposite to the side branch origin for stent type and recross strategy
time frame: Baseline
measure: Optical coherence tomography endpoints: Distance between malapposed strut and vessel wall in all segments for stent type and recross strategy
time frame: Baseline
measure: Optical coherence tomography endpoints: Minimum expansion of the stents expressed as absolute area and percentage of the closest reference area, for stent type and recross strategy
time frame: Baseline
measure: Optical coherence tomography endpoints: Ostial stent area stenosis by optical coherence tomography (side branch reference area by 3D QCA)
time frame: Baseline
measure: Angiographic endpoints: Segmental assessment; Proximal edge, proximal main vessel, bifurcation segment, distal main vessel, distal edge, ostial 5 mm of side branch. Pre and post side branch intervention
time frame: Baseline
measure: Ostial side branch area stenosis
time frame: Baseline
measure: Ostial side branch acute gain after main vessel (MV) stenting
time frame: Baseline
measure: Minimal luminal area of all segments
time frame: Baseline
measure: Angiographic area stenosis of all other segments
time frame: Baseline
arm group label: Medtronic Resolute Integrity stent
arm group type: Experimental
description: Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium
arm group label: OCT
arm group type: Experimental
description: OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.
arm group label: Angiography
arm group type: Active Comparator
description: Angiography to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.
arm group label: Xience Prime stent
arm group type: Active Comparator
description: Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium
intervention type: Device
intervention name: Xience Prime Stent
arm group label: Angiography
arm group label: OCT
other name: Stent
intervention type: Device
intervention name: Medtronic Resolute Integrity stent
arm group label: Angiography
arm group label: OCT
other name: Stent
intervention type: Procedure
intervention name: Angiography
arm group label: Medtronic Resolute Integrity stent
arm group label: Xience Prime stent
other name: CAG
intervention type: Procedure
intervention name: OCT
arm group label: Medtronic Resolute Integrity stent
arm group label: Xience Prime stent
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 Skejby
last name: Niels R Holm, MD
phone: +45 7845 0000
phone ext: 52254
email: niels.holm@ki.au.dk
last name: Evald H Christiansen, MD
phone: +45 7845 0000
phone ext: 52028
email: hellbarg@rm.dk
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Belgium
country: Denmark
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital Skejby
investigator full name: Niels Ramsing Holm
investigator title: MD
mesh term: Coronary Disease