<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/NCT01689688</url>
  </required_header>
  <id_info>
    <org_study_id>KobeU-001</org_study_id>
    <secondary_id>R000008722</secondary_id>
    <nct_id>NCT01689688</nct_id>
  </id_info>
  <brief_title>Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography</brief_title>
  <acronym>HEAL</acronym>
  <official_title>Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kobe University</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kobe University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate serial changes of neointimal coverage after&#xD;
      everolimus-eluting stent implantation at 3-, 6- and 12-months by OCT examination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Late and very late stent thrombosis is current main issue after introduction of drug-eluting&#xD;
      stents .Possible causes of these stent thromboses include thrombus formation resulting from&#xD;
      delayed neointimal coverage, spasms occurring at the distal end of the stent implantation&#xD;
      site, positive remodeling of coronary arteries caused by local immune reaction to paclitaxel&#xD;
      or rapamycin, and vascular endothelial damage induced by the polymer. For BMS, neointimal&#xD;
      coverage begins within the first one month after stent implantation and almost completes in&#xD;
      three months. For DES, sirolimus eluting stents (SES) for example, neointimal coverage is&#xD;
      markedly delayed after stent implantation and the exposed stent struts may be largely&#xD;
      attributable to the occurrence of late stent thrombosis.&#xD;
&#xD;
      On the other hand, everolimus eluting stents (EES), which have a thinner stent strut layer&#xD;
      and improved polymer biocompatibility, it has been reported that earlier and more normal&#xD;
      neointimal coverage can be achieved compared with other first-generation DESs, SES and&#xD;
      paclitaxel eluting stents (PES). These findings suggest that coverage with vascular&#xD;
      endothelium differs among different DES platforms. Optical coherence tomography (OCT) has a&#xD;
      resolution of 15 to 20 μm, which is approximately 10 times higher than that of intravascular&#xD;
      ultrasound (IVUS). It is therefore necessary to use OCT to accurately evaluate&#xD;
      cross-sectional images of the stent struts covered with vascular endothelium. However, no&#xD;
      studies have reported the results of continuous observation and evaluation of EES covered&#xD;
      with endothelium.&#xD;
&#xD;
      Therefore, the investigators investigate time course of neointimal coverage of EES through&#xD;
      detailed evaluation by OCT of neointimal coverage at 3, 6, and 12 months after stent&#xD;
      implantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2013</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>The percentage of neointimal coverage</measure>
    <time_frame>12 months</time_frame>
    <description>The primary endpoint is to evaluate the neointimal coverage of XIENCE everolimus eluting stent (EES) in 12 month after stent implantation by Optical coherence tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of neointimal coverage</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of neointimal coverage</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Coronary Heart Disease</condition>
  <arm_group>
    <arm_group_label>EES-XIENCE V</arm_group_label>
    <description>Groups who were treated with XIENCE V® everolimus eluting stent</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are percutaenous coronary intervention and stenting and eligible to receive&#xD;
        dual antiplatelet therapy at least more than 6 month.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Older than 20 years old.&#xD;
&#xD;
          2. Indication of PCI.&#xD;
&#xD;
          3. To agree to review and record all the clinical course in this research protocol.&#xD;
&#xD;
          4. The patient who are eligible to receive dual antiplatelet therapy at least more than 6&#xD;
             month.&#xD;
&#xD;
          5. Informed concent with the document signed by the patients.&#xD;
&#xD;
        The patient have to correspond to all the above items at the time of registration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient who died during the research&#xD;
&#xD;
          2. The patient with Stent thrombosis during the research.&#xD;
&#xD;
          3. Previous history of pancytopenia, liver function, renal dysfunction, hypersensitive&#xD;
             history of the drug.&#xD;
&#xD;
          4. Low ejection fraction (LVEF&lt;=30%), an impaired liver function, and renal dysfunction&#xD;
             (eGFR&lt;=30)&#xD;
&#xD;
          5. The patient excluded from a safety of a thiazolidine derivative.&#xD;
&#xD;
        lesion exclusion criteria&#xD;
&#xD;
          1. left main artery&#xD;
&#xD;
          2. severe calcification&#xD;
&#xD;
          3. stent restenosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Toshiro Shinke</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kobe University Graduate School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kobe University Graduate School of Medicine</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Toshiro Shinke, MD, PhD</last_name>
      <phone>+81.78.382.5846</phone>
      <email>shinke@med.kobe-u.ac.jp</email>
    </contact>
    <investigator>
      <last_name>Toshiro Shinke, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 6, 2013</last_update_submitted>
  <last_update_submitted_qc>September 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kobe University</investigator_affiliation>
    <investigator_full_name>Toshiro Shinke, MD, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</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/NCT01689688
org study id: KobeU-001
secondary id: R000008722
nct id: NCT01689688
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate serial changes of neointimal coverage after
      everolimus-eluting stent implantation at 3-, 6- and 12-months by OCT examination.
Late and very late stent thrombosis is current main issue after introduction of drug-eluting
      stents .Possible causes of these stent thromboses include thrombus formation resulting from
      delayed neointimal coverage, spasms occurring at the distal end of the stent implantation
      site, positive remodeling of coronary arteries caused by local immune reaction to paclitaxel
      or rapamycin, and vascular endothelial damage induced by the polymer. For BMS, neointimal
      coverage begins within the first one month after stent implantation and almost completes in
      three months. For DES, sirolimus eluting stents (SES) for example, neointimal coverage is
      markedly delayed after stent implantation and the exposed stent struts may be largely
      attributable to the occurrence of late stent thrombosis.

      On the other hand, everolimus eluting stents (EES), which have a thinner stent strut layer
      and improved polymer biocompatibility, it has been reported that earlier and more normal
      neointimal coverage can be achieved compared with other first-generation DESs, SES and
      paclitaxel eluting stents (PES). These findings suggest that coverage with vascular
      endothelium differs among different DES platforms. Optical coherence tomography (OCT) has a
      resolution of 15 to 20 μm, which is approximately 10 times higher than that of intravascular
      ultrasound (IVUS). It is therefore necessary to use OCT to accurately evaluate
      cross-sectional images of the stent struts covered with vascular endothelium. However, no
      studies have reported the results of continuous observation and evaluation of EES covered
      with endothelium.

      Therefore, the investigators investigate time course of neointimal coverage of EES through
      detailed evaluation by OCT of neointimal coverage at 3, 6, and 12 months after stent
      implantation.
observational model: Cohort
time perspective: Prospective
measure: The percentage of neointimal coverage
time frame: 12 months
description: The primary endpoint is to evaluate the neointimal coverage of XIENCE everolimus eluting stent (EES) in 12 month after stent implantation by Optical coherence tomography
measure: The percentage of neointimal coverage
time frame: 3 months
measure: The percentage of neointimal coverage
time frame: 6 months
arm group label: EES-XIENCE V
description: Groups who were treated with XIENCE V® everolimus eluting stent
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Toshiro Shinke
role: Principal Investigator
affiliation: Kobe University Graduate School of Medicine
facility: 
status: Recruiting
contact: 
investigator: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Kobe University
investigator full name: Toshiro Shinke, MD, PhD
investigator title: Associate Professor
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia