<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/NCT01711931</url>
  </required_header>
  <id_info>
    <org_study_id>043/12-CER-FR</org_study_id>
    <nct_id>NCT01711931</nct_id>
  </id_info>
  <brief_title>Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents</brief_title>
  <acronym>EVERBIOII</acronym>
  <official_title>Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Freiburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Freiburg</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy and safety of everolimus- and&#xD;
      biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.&#xD;
&#xD;
      The null hypothesis to be rejected is that there is no significant difference with regard to&#xD;
      lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR&#xD;
      at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting&#xD;
      bioresorbable vascular scaffold stents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lumen Late Loss</measure>
    <time_frame>9 months</time_frame>
    <description>as assessed by quantitative coronary angiogram</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device-oriented major adverse cardiac events</measure>
    <time_frame>6 months, 1, 2, 5 years</time_frame>
    <description>The composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel) and target lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-oriented major adverse cardiac events</measure>
    <time_frame>6 months, 1, 2, 5 years</time_frame>
    <description>The composite of all-cause mortality, any myocardial infarction and any revascularization</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>up to 5 years</time_frame>
    <description>possible, probable and definite stent thrombosis</description>
  </other_outcome>
  <other_outcome>
    <measure>Periprocedural Complications (occurring &lt;48 hours after the Intervention)</measure>
    <time_frame>Periprocedural</time_frame>
    <description>Type 4A MI Dissection Perforation</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Everolimus-eluting bioresorbable vascular scaffold stents</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Everolimus-eluting stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Biolimus-eluting stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantation of everolimus-eluting bioresorbable vascular scaffold stent</intervention_name>
    <arm_group_label>Everolimus-eluting bioresorbable vascular scaffold stents</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantation of everolimus-eluting stents</intervention_name>
    <arm_group_label>Everolimus-eluting stent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantation of biolimus-eluting stents</intervention_name>
    <arm_group_label>Biolimus-eluting stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective PCI&#xD;
&#xD;
          -  ability and willingness to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ST-elevation myocardial infarction in the previous 48 hours&#xD;
&#xD;
          -  moderate to severe renal failure (defined as creatinine clearance of 30-60 ml/min and&#xD;
             &lt;30ml/min respectively)&#xD;
&#xD;
          -  known or presumed hypersensitivity to heparin, antiplatelet drugs and hypersensitivity&#xD;
             to contrast dye incontrollable with premedication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stéphane Cook, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>University of Freiburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mario Togni, Professor</last_name>
    <role>Study Director</role>
    <affiliation>University of Freiburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Serban Puricel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Freiburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fribourg Cantonal Hospital</name>
      <address>
        <city>Fribourg</city>
        <zip>1708</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Arroyo D, Togni M, Puricel S, Gerard B, Sonja L, Corpataux N, Villeneuve H, Boute E, Stauffer JC, Goy JJ, Cook S. Comparison of everolimus-eluting and biolimus-eluting coronary stents with everolimus-eluting bioresorbable scaffold: study protocol of the randomized controlled EVERBIO II trial. Trials. 2014 Jan 7;15:9. doi: 10.1186/1745-6215-15-9.</citation>
    <PMID>24398143</PMID>
  </results_reference>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>October 14, 2021</last_update_submitted>
  <last_update_submitted_qc>October 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Freiburg</investigator_affiliation>
    <investigator_full_name>Stéphane Cook, Prof</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>percutaneous coronary intervention</keyword>
  <keyword>bioresorbable vascular scaffold stents</keyword>
  <keyword>everolimus</keyword>
  <keyword>biolimus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT01711931
org study id: 043/12-CER-FR
nct id: NCT01711931
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare the efficacy and safety of everolimus- and
      biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.

      The null hypothesis to be rejected is that there is no significant difference with regard to
      lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR
      at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting
      bioresorbable vascular scaffold stents.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Lumen Late Loss
time frame: 9 months
description: as assessed by quantitative coronary angiogram
measure: Device-oriented major adverse cardiac events
time frame: 6 months, 1, 2, 5 years
description: The composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel) and target lesion revascularization
measure: Patient-oriented major adverse cardiac events
time frame: 6 months, 1, 2, 5 years
description: The composite of all-cause mortality, any myocardial infarction and any revascularization
measure: Stent thrombosis
time frame: up to 5 years
description: possible, probable and definite stent thrombosis
measure: Periprocedural Complications (occurring <48 hours after the Intervention)
time frame: Periprocedural
description: Type 4A MI Dissection Perforation
arm group label: Everolimus-eluting bioresorbable vascular scaffold stents
arm group type: Active Comparator
arm group label: Everolimus-eluting stent
arm group type: Active Comparator
arm group label: Biolimus-eluting stent
arm group type: Active Comparator
intervention type: Device
intervention name: Implantation of everolimus-eluting bioresorbable vascular scaffold stent
arm group label: Everolimus-eluting bioresorbable vascular scaffold stents
intervention type: Device
intervention name: Implantation of everolimus-eluting stents
arm group label: Everolimus-eluting stent
intervention type: Device
intervention name: Implantation of biolimus-eluting stents
arm group label: Biolimus-eluting stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Stéphane Cook, Professor
role: Study Chair
affiliation: University of Freiburg
last name: Mario Togni, Professor
role: Study Director
affiliation: University of Freiburg
last name: Serban Puricel, MD
role: Principal Investigator
affiliation: University of Freiburg
facility: 
country: Switzerland
citation: Arroyo D, Togni M, Puricel S, Gerard B, Sonja L, Corpataux N, Villeneuve H, Boute E, Stauffer JC, Goy JJ, Cook S. Comparison of everolimus-eluting and biolimus-eluting coronary stents with everolimus-eluting bioresorbable scaffold: study protocol of the randomized controlled EVERBIO II trial. Trials. 2014 Jan 7;15:9. doi: 10.1186/1745-6215-15-9.
PMID: 24398143
responsible party type: Principal Investigator
investigator affiliation: University of Freiburg
investigator full name: Stéphane Cook, Prof
investigator title: Principal Investigator
mesh term: Coronary Artery Disease
mesh term: Everolimus