<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/NCT02982057</url>
  </required_header>
  <id_info>
    <org_study_id>Non Culprit Lesion Study</org_study_id>
    <nct_id>NCT02982057</nct_id>
  </id_info>
  <brief_title>Non Culprit Lesion Study</brief_title>
  <official_title>A Randomized Trial of the Treatment of Non- Culprit Lesion After STEMI: Bioresorbable Vascular Scaffold Versus Optimal Medical Therapy (NCLstudy)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to compare the evolution of non culprit lesions after&#xD;
      treatment by BVS versus optimal medical therapy at 2-years follow- up&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives and hypothesis: scaffolding a non culprit /vulnerable coronary plaque with BVS&#xD;
      could facilitate the stabilization process into the atherosclerotic plaque with modifications&#xD;
      of plaque morphology, especially the lipid content which is considered as one of the main&#xD;
      factor leading to recurrent MACE after an ACS.&#xD;
&#xD;
      The interaction between the polymer Platform and the vessel wall, the effect of the&#xD;
      everolimus on neointima growth and cellular response into the media could reduce the&#xD;
      inflammatory process into the vulnerable plaque could be different Under OMT and BVS&#xD;
      implantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</primary_completion_date>
  <phase>Phase 3</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>measure size of the vulnerable plaque</measure>
    <time_frame>2 years</time_frame>
    <description>the size of the vulnerable plaque measured by angio FU at 2 years with an investigation of the same segment than at baseline.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>STEMI</condition>
  <arm_group>
    <arm_group_label>Bioresorbable vascular scaffold(BVS)+ OMT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>hypothesis: scaffolding a non culprit coronary plaque with BVS could facilitate the stabilization process into the atherosclerotic plaque with modification of plaque morphology.&#xD;
Intervention:Device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OMT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Comparator with ONLY optimal medical treatment (OMT): the aim of the study is to compare the evolution of non culprit lesions after treatment by BVS versus Optimal Medical Therapy at 2 years follow- up.&#xD;
Intervention: medical treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>the ABSORB:bioresorbable vascular scaffold</intervention_name>
    <arm_group_label>Bioresorbable vascular scaffold(BVS)+ OMT</arm_group_label>
    <other_name>to compare to optimal medical treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>O.M.T</intervention_name>
    <arm_group_label>OMT</arm_group_label>
    <other_name>to compare with device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  STEMI and multivessel ASCL&#xD;
&#xD;
          -  Successful and uneventful primary PCI&#xD;
&#xD;
          -  Non culprit lesion &gt; /= 2.5mm RVD suitable for investigation by FFR&#xD;
&#xD;
          -  At least one segment of minimum 10 mm length containing a non culprit lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non compliant profile&#xD;
&#xD;
          -  patient not able to sign an IC&#xD;
&#xD;
          -  cardiogenic shock&#xD;
&#xD;
          -  left main disease&#xD;
&#xD;
          -  GFR&lt;30ml/min/m2&#xD;
&#xD;
          -  previous CABG&#xD;
&#xD;
          -  LVEF&lt;35%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>StLuc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 7, 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>May 4, 2020</last_update_submitted>
  <last_update_submitted_qc>May 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02982057
org study id: Non Culprit Lesion Study
nct id: NCT02982057
lead sponsor: 
has dmc: Yes
The aim of the present study is to compare the evolution of non culprit lesions after
      treatment by BVS versus optimal medical therapy at 2-years follow- up
Objectives and hypothesis: scaffolding a non culprit /vulnerable coronary plaque with BVS
      could facilitate the stabilization process into the atherosclerotic plaque with modifications
      of plaque morphology, especially the lipid content which is considered as one of the main
      factor leading to recurrent MACE after an ACS.

      The interaction between the polymer Platform and the vessel wall, the effect of the
      everolimus on neointima growth and cellular response into the media could reduce the
      inflammatory process into the vulnerable plaque could be different Under OMT and BVS
      implantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: measure size of the vulnerable plaque
time frame: 2 years
description: the size of the vulnerable plaque measured by angio FU at 2 years with an investigation of the same segment than at baseline.
arm group label: Bioresorbable vascular scaffold(BVS)+ OMT
arm group type: Active Comparator
description: hypothesis: scaffolding a non culprit coronary plaque with BVS could facilitate the stabilization process into the atherosclerotic plaque with modification of plaque morphology.
Intervention:Device
arm group label: OMT
arm group type: Active Comparator
description: Comparator with ONLY optimal medical treatment (OMT): the aim of the study is to compare the evolution of non culprit lesions after treatment by BVS versus Optimal Medical Therapy at 2 years follow- up.
Intervention: medical treatment
intervention type: Device
intervention name: the ABSORB:bioresorbable vascular scaffold
arm group label: Bioresorbable vascular scaffold(BVS)+ OMT
other name: to compare to optimal medical treatment
intervention type: Drug
intervention name: O.M.T
arm group label: OMT
other name: to compare with device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: ST Elevation Myocardial Infarction
sharing ipd: Yes