<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/NCT02981134</url>
  </required_header>
  <id_info>
    <org_study_id>AMCCV2016-25</org_study_id>
    <nct_id>NCT02981134</nct_id>
  </id_info>
  <brief_title>The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease</brief_title>
  <acronym>CT BVS</acronym>
  <official_title>The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease; A Single Center, Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jung-min Ahn</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CardioVascular Research Foundation, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate usefulness of coronary computed tomographic scan for&#xD;
      prediction of clinical events after everolimus-eluting bioabsorbable scaffold implantation&#xD;
      for coronary artery disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This study will be revived with retrospective design.&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Computed tomographic scan parameters</measure>
    <time_frame>3 years</time_frame>
    <description>Computed tomographic scan parameters predicting clinical outcomes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Restenosis</measure>
    <time_frame>1 year</time_frame>
    <description>Restenosis on computed tomographic scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombosis</measure>
    <time_frame>1 year</time_frame>
    <description>Thrombosis on computed tomographic scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumen loss</measure>
    <time_frame>1 year</time_frame>
    <description>lumen loss: the change in minimal lumen diameter on computed tomographic scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive predictive value</measure>
    <time_frame>3 years</time_frame>
    <description>Positive predictive value on computed tomographic scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes</measure>
    <time_frame>3 years</time_frame>
    <description>Death, target vessel myocardial infarction, clinically driven revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of analyzable lesion</measure>
    <time_frame>3 years</time_frame>
    <description>small vessel defined diameter less than 3.0 mm, bifurcation, overlapped lesion</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Coronary Disease</condition>
  <arm_group>
    <arm_group_label>bioabsorbable scaffold</arm_group_label>
    <description>Patients with BVS(bioabsorbable scaffold) for coronary stenosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computed tomographic scan</intervention_name>
    <description>after 1year of BVS implantation, computed tomographic scan will be performed</description>
    <arm_group_label>bioabsorbable scaffold</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with Bioresobable Vascular Scaffold for coronary disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients treated withBioresobable Vascular Scaffold for coronary disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergy to contrast&#xD;
&#xD;
          -  Serum Creatinine &gt; 2.0 mg/dl&#xD;
&#xD;
          -  Severe arrhythmia&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Jung-min Ahn</investigator_full_name>
    <investigator_title>Assistant professor, Department of Cardiology, Heart Institute, University of Ulsan College of Medicine</investigator_title>
  </responsible_party>
  <keyword>bioabsorbable scaffold</keyword>
  <keyword>computed tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02981134
org study id: AMCCV2016-25
nct id: NCT02981134
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate usefulness of coronary computed tomographic scan for
      prediction of clinical events after everolimus-eluting bioabsorbable scaffold implantation
      for coronary artery disease.
observational model: Cohort
time perspective: Prospective
measure: Computed tomographic scan parameters
time frame: 3 years
description: Computed tomographic scan parameters predicting clinical outcomes
measure: Restenosis
time frame: 1 year
description: Restenosis on computed tomographic scan
measure: Thrombosis
time frame: 1 year
description: Thrombosis on computed tomographic scan
measure: Lumen loss
time frame: 1 year
description: lumen loss: the change in minimal lumen diameter on computed tomographic scan
measure: Positive predictive value
time frame: 3 years
description: Positive predictive value on computed tomographic scan
measure: Clinical outcomes
time frame: 3 years
description: Death, target vessel myocardial infarction, clinically driven revascularization
measure: Proportion of analyzable lesion
time frame: 3 years
description: small vessel defined diameter less than 3.0 mm, bifurcation, overlapped lesion
arm group label: bioabsorbable scaffold
description: Patients with BVS(bioabsorbable scaffold) for coronary stenosis
intervention type: Procedure
intervention name: Computed tomographic scan
description: after 1year of BVS implantation, computed tomographic scan will be performed
arm group label: bioabsorbable scaffold
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Asan Medical Center
investigator full name: Jung-min Ahn
investigator title: Assistant professor, Department of Cardiology, Heart Institute, University of Ulsan College of Medicine
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: Undecided