<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/NCT02253108</url>
  </required_header>
  <id_info>
    <org_study_id>1-10-72-125-14</org_study_id>
    <nct_id>NCT02253108</nct_id>
  </id_info>
  <brief_title>The OCT SORT-OUT VIII Study</brief_title>
  <acronym>OCT SORT-OUT</acronym>
  <official_title>Randomized Comparison of the Biolimus-eluting Biomatrix Neoflex™ og Everolimus-eluting SYNERGY™ Stents in All-comer Patients With Ischemic Heart Disease - The OCT SORT-OUT VIII</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital Skejby</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biosensors International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Scientific Corporation</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>
      The purpose of this study is to compare early vessel healing after implantation of SYNERGY&#xD;
      drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, open label, single blind, randomized study with inclusion of 160 patients in two&#xD;
      equal sized cohorts (A and B). Angiographic follow-up with optical coherence tomography (OCT)&#xD;
      is performed at 1 month (Cohort A) and 3 months (Cohort B). Randomization 1:1 to SYNERGY or&#xD;
      BioMatrix Neoflex. The Cohorts are included consecutively, Cohort A first.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Coronary Stent Healing Index</measure>
    <time_frame>1 or 3 months</time_frame>
    <description>Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Uncovered stent struts</measure>
    <time_frame>1 or 3 months</time_frame>
    <description>Uncovered stent struts 2%=1, 5%=2, 10%=3, 15%=4, 20%=5, 25%=6, 30%=7, 35%=8, 40%=9</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>Uncovered stent struts in front of side branchs (SB), on acquired or persistent malapposed struts10%=1, 20%=2, 30%=3 etc to 100%=0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Persistent malapposition</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>Persistent malapposition: &gt;2 adjacent struts of at least 1 mm length =1; &gt;2 mm=2; &gt;3 mm=3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neointimal thickness in one frame or lumen mean diameter stenosis</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>Neointimal thickness in one frame or lumen mean diameter stenosis &gt;200=1; &gt;300=2; &gt;400=3 or diameter stenosis &gt;50%=4; &gt;75%=5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acquired malapposition</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>Acquired malapposition: &gt;2 adjacent struts of at least 1 mm length =2; &gt; 2 mm=4; &gt; 3 mm=6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulated extra stent lumen increase in matched cross sectional analysis</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Malapposition</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>Detectable separation between the vessel wall and strut in a cross section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coverage</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>Detectable tissue covering the strut</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fracture</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>Discontinuity of a strut evaluated by 3D reconstruction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neointimal thickness (NIT)</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>Thickness of intima from leading strut surface to lumen boarder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumen area</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>Area of lumen in cross section</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent area</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>Area of stent in cross section</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area stenosis (AS) %</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>Minimal luminal area/reference area (interpolated)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum expansion of the stent</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>Expressed as absolute area and percentage of the closest reference area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late recoil</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>Loss in stent area from baseline to follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumen late loss</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>Loss in minimal lumen area from baseline to follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extra stent lumen</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>Area outside stent boarder limited by lumen boarder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaginations</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>Counts and descriptive by size (volume and depth)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombus on struts</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>In final OCT after implantation and at follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute expansion and late recoil</measure>
    <time_frame>Baseline, 1 and 3 months</time_frame>
    <description>In segments with; 1)calcified plaque, 2)lipid plaque, 3)area after predilatation &lt;30% of reference area, 4)stenosed segments (&gt;50% AS) with no dissections after predilatation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Failure (TLF)</measure>
    <time_frame>Within 12 months</time_frame>
    <description>Stent related combined endpoint of Target Lesion Failure (TLF) hierarchically as cardiac death, non-index procedure related AMI (defined as AMI not clearly related to another lesion than the target lesion), or Target Lesion Revascularisation (TLR) (by PCI or CABG - TLR if significant stenosis + 5mm distal/proximal)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death</measure>
    <time_frame>Baseline, 12, 24, 36, 48 and 60 months</time_frame>
    <description>Stent related, major adverse cardiac events (MACE), serious complication at procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-index procedure related acute myocardial infarction (AMI)</measure>
    <time_frame>Baseline and within 12, 24, 36, 48 and 60 months</time_frame>
    <description>Defined as AMI not clearly related to another lesion than the target lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Revascularisation (TLR)</measure>
    <time_frame>Baseline and within 12, 24, 36, 48 and 60 months</time_frame>
    <description>New revascularisation of TLR by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) (TLR if significant stenosis += 5 mm distal/proximal)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death</measure>
    <time_frame>12, 24, 36, 48 and 60 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>Baseline, 1, 12, 24, 36, 48 and 60 months</time_frame>
    <description>According to ARC criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success rate</measure>
    <time_frame>Baseline</time_frame>
    <description>Defined as the frequency of successful implantation with residual stenosis &lt;20% of the study stent in all the stenoses scheduled to be treated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural success rate</measure>
    <time_frame>Baseline</time_frame>
    <description>Defined as the frequency of successful implantation with residual stenosis &lt;20% of the study stent in all the stenoses scheduled to be treated and without serious complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Angina Pectoris</condition>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>SYNERGY drug eluting stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Everolimus eluting bioresorbable polymer stent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biomatrix NeoFlex drug eluting stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Biolimus eluting bioresorbable polymer stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Everolimus eluting bioresorbable polymer stent</intervention_name>
    <arm_group_label>SYNERGY drug eluting stent</arm_group_label>
    <other_name>SYNERGY</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biolimus eluting bioresorbable polymer stent</intervention_name>
    <arm_group_label>Biomatrix NeoFlex drug eluting stent</arm_group_label>
    <other_name>Biomatrix NeoFlex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt;18 years to be treated with one or more drug-eluting stents in a coronary&#xD;
             artery at Aarhus University Hospital or Odense University Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Do not wish to participate&#xD;
&#xD;
          -  Unable to provide written informed consent&#xD;
&#xD;
          -  Domicile outside Denmark&#xD;
&#xD;
          -  Do not speak Danish&#xD;
&#xD;
          -  Inclusion in the SORT-OUT VIII study&#xD;
&#xD;
          -  Inclusion in other stent studies&#xD;
&#xD;
          -  Expected survival &lt;1 year&#xD;
&#xD;
          -  Allergy to aspirin, clopidogrel, prasugrel or ticagrelor&#xD;
&#xD;
          -  Hypersensitivity to everolimus or biolimus&#xD;
&#xD;
          -  The operator wishes to use other DES&#xD;
&#xD;
          -  Reduced renal function; creatinine&gt; 120 mmol / L&#xD;
&#xD;
          -  Only bare metal stent (BMS) implantation&#xD;
&#xD;
          -  Only plain old balloon angioplasty (POBA)&#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>Evald H Christiansen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University Hospital, Skejby</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>October 17, 2022</last_update_submitted>
  <last_update_submitted_qc>October 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital Skejby</investigator_affiliation>
    <investigator_full_name>Evald Hoej Christiansen</investigator_full_name>
    <investigator_title>MD, phd</investigator_title>
  </responsible_party>
  <keyword>DES</keyword>
  <keyword>Angina pectoris</keyword>
  <keyword>Stent</keyword>
  <keyword>Optical coherence tomography</keyword>
  <keyword>Stent thrombosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Everolimus</mesh_term>
  </intervention_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/NCT02253108
org study id: 1-10-72-125-14
nct id: NCT02253108
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to compare early vessel healing after implantation of SYNERGY
      drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.
Prospective, open label, single blind, randomized study with inclusion of 160 patients in two
      equal sized cohorts (A and B). Angiographic follow-up with optical coherence tomography (OCT)
      is performed at 1 month (Cohort A) and 3 months (Cohort B). Randomization 1:1 to SYNERGY or
      BioMatrix Neoflex. The Cohorts are included consecutively, Cohort A first.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Coronary Stent Healing Index
time frame: 1 or 3 months
description: Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)
measure: Uncovered stent struts
time frame: 1 or 3 months
description: Uncovered stent struts 2%=1, 5%=2, 10%=3, 15%=4, 20%=5, 25%=6, 30%=7, 35%=8, 40%=9
measure: Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts
time frame: 1 and 3 months
description: Uncovered stent struts in front of side branchs (SB), on acquired or persistent malapposed struts10%=1, 20%=2, 30%=3 etc to 100%=0
measure: Persistent malapposition
time frame: 1 and 3 months
description: Persistent malapposition: >2 adjacent struts of at least 1 mm length =1; >2 mm=2; >3 mm=3
measure: Neointimal thickness in one frame or lumen mean diameter stenosis
time frame: 1 and 3 months
description: Neointimal thickness in one frame or lumen mean diameter stenosis >200=1; >300=2; >400=3 or diameter stenosis >50%=4; >75%=5
measure: Acquired malapposition
time frame: 1 and 3 months
description: Acquired malapposition: >2 adjacent struts of at least 1 mm length =2; > 2 mm=4; > 3 mm=6
measure: Cumulated extra stent lumen increase in matched cross sectional analysis
time frame: 1 and 3 months
description: Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area)
measure: Malapposition
time frame: Baseline, 1 and 3 months
description: Detectable separation between the vessel wall and strut in a cross section.
measure: Coverage
time frame: Baseline, 1 and 3 months
description: Detectable tissue covering the strut
measure: Fracture
time frame: Baseline, 1 and 3 months
description: Discontinuity of a strut evaluated by 3D reconstruction
measure: Neointimal thickness (NIT)
time frame: Baseline, 1 and 3 months
description: Thickness of intima from leading strut surface to lumen boarder
measure: Lumen area
time frame: Baseline, 1 and 3 months
description: Area of lumen in cross section
measure: Stent area
time frame: Baseline, 1 and 3 months
description: Area of stent in cross section
measure: Area stenosis (AS) %
time frame: Baseline, 1 and 3 months
description: Minimal luminal area/reference area (interpolated)
measure: Minimum expansion of the stent
time frame: Baseline, 1 and 3 months
description: Expressed as absolute area and percentage of the closest reference area
measure: Late recoil
time frame: Baseline, 1 and 3 months
description: Loss in stent area from baseline to follow-up
measure: Lumen late loss
time frame: Baseline, 1 and 3 months
description: Loss in minimal lumen area from baseline to follow-up
measure: Extra stent lumen
time frame: Baseline, 1 and 3 months
description: Area outside stent boarder limited by lumen boarder
measure: Evaginations
time frame: Baseline, 1 and 3 months
description: Counts and descriptive by size (volume and depth)
measure: Thrombus on struts
time frame: Baseline, 1 and 3 months
description: In final OCT after implantation and at follow-up
measure: Acute expansion and late recoil
time frame: Baseline, 1 and 3 months
description: In segments with; 1)calcified plaque, 2)lipid plaque, 3)area after predilatation <30% of reference area, 4)stenosed segments (>50% AS) with no dissections after predilatation
measure: Target Lesion Failure (TLF)
time frame: Within 12 months
description: Stent related combined endpoint of Target Lesion Failure (TLF) hierarchically as cardiac death, non-index procedure related AMI (defined as AMI not clearly related to another lesion than the target lesion), or Target Lesion Revascularisation (TLR) (by PCI or CABG - TLR if significant stenosis + 5mm distal/proximal)
measure: Cardiac death
time frame: Baseline, 12, 24, 36, 48 and 60 months
description: Stent related, major adverse cardiac events (MACE), serious complication at procedure
measure: Non-index procedure related acute myocardial infarction (AMI)
time frame: Baseline and within 12, 24, 36, 48 and 60 months
description: Defined as AMI not clearly related to another lesion than the target lesion
measure: Target Lesion Revascularisation (TLR)
time frame: Baseline and within 12, 24, 36, 48 and 60 months
description: New revascularisation of TLR by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) (TLR if significant stenosis += 5 mm distal/proximal)
measure: All-cause death
time frame: 12, 24, 36, 48 and 60 months
measure: Stent thrombosis
time frame: Baseline, 1, 12, 24, 36, 48 and 60 months
description: According to ARC criteria
measure: Device success rate
time frame: Baseline
description: Defined as the frequency of successful implantation with residual stenosis <20% of the study stent in all the stenoses scheduled to be treated
measure: Procedural success rate
time frame: Baseline
description: Defined as the frequency of successful implantation with residual stenosis <20% of the study stent in all the stenoses scheduled to be treated and without serious complications
arm group label: SYNERGY drug eluting stent
arm group type: Experimental
description: Everolimus eluting bioresorbable polymer stent
arm group label: Biomatrix NeoFlex drug eluting stent
arm group type: Experimental
description: Biolimus eluting bioresorbable polymer stent
intervention type: Device
intervention name: Everolimus eluting bioresorbable polymer stent
arm group label: SYNERGY drug eluting stent
other name: SYNERGY
intervention type: Device
intervention name: Biolimus eluting bioresorbable polymer stent
arm group label: Biomatrix NeoFlex drug eluting stent
other name: Biomatrix NeoFlex
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evald H Christiansen, 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: Evald Hoej Christiansen
investigator title: MD, phd
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: Angina Pectoris
mesh term: Infarction
mesh term: Everolimus