<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/NCT01674803</url>
  </required_header>
  <id_info>
    <org_study_id>BIO-RESORT</org_study_id>
    <nct_id>NCT01674803</nct_id>
  </id_info>
  <brief_title>Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion (BIO-RESORT)</brief_title>
  <acronym>BIO-RESORT</acronym>
  <official_title>Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion: Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Foundation of Cardiovascular Research and Education Enschede</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Foundation of Cardiovascular Research and Education Enschede</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has&#xD;
      led to a significant reduction in morbidity. However, the first generation of these devices&#xD;
      had no positive impact on the mortality after PCI (compared to bare metal stents), which was&#xD;
      greatly attributed to a somewhat increased incidence of late and very late stent thrombosis.&#xD;
      Concerns about the role of durable polymers as a potential trigger of inflammation and&#xD;
      finally adverse events also led to the development of DES with biodegradable coatings, which&#xD;
      leave after degradation of the coating only a bare metal stent in the vessel wall that does&#xD;
      not induce an inflammatory response. While such biodegradable polymer DES are increasingly&#xD;
      used in clinical practice, there is no data available from head-to-head comparisons between&#xD;
      biodegradable and contemporary third generation durable polymer DES.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2012</start_date>
  <completion_date type="Actual">August 25, 2020</completion_date>
  <primary_completion_date type="Actual">August 24, 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Target vessel failure (TVF)</measure>
    <time_frame>1 year</time_frame>
    <description>Target vessel failure is a combined endpoint of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target lesion failure (TLF)</measure>
    <time_frame>1 year</time_frame>
    <description>Target lesion failure is a combined endpoint of cardiac death, target vessel related myocardial infarction, and clinically driven target lesion revascularization</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3514</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Angina Pectoris</condition>
  <condition>Angina, Unstable</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Coronary Stenosis</condition>
  <condition>Coronary Restenosis</condition>
  <arm_group>
    <arm_group_label>Orsiro</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Synergy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Resolute Integrity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Orsiro</intervention_name>
    <description>biodegradable polymer sirolimus eluting stent</description>
    <arm_group_label>Orsiro</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Synergy</intervention_name>
    <description>biodegradable polymer everolimus eluting stent</description>
    <arm_group_label>Synergy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Resolute Integrity</intervention_name>
    <description>durable polymer zotarolimus-eluting stent</description>
    <arm_group_label>Resolute Integrity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum age of 18 years.&#xD;
&#xD;
          -  Significant coronary artery disease and lesion(s) eligible for treatment with drug&#xD;
             eluting stents according to clinical guidelines and/or the operators' judgement.&#xD;
&#xD;
          -  Capable of providing informed consent.&#xD;
&#xD;
          -  Patients with all clinical syndromes will be enrolled without any exclusion based on&#xD;
             number, type, location, or length of lesions to be treated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known intolerance to components of one of the stents that will be investigated or&#xD;
             known intolerance to antithrombotic and/or anticoagulant therapy that prevents&#xD;
             adherence to dual antiplatelet therapy.&#xD;
&#xD;
          -  Planned elective surgical procedure necessitating interruption of dual antiplatelet&#xD;
             therapy during the first 6 months after randomization.&#xD;
&#xD;
          -  Participation in another randomized drug or device trial before reaching primary&#xD;
             endpoint.&#xD;
&#xD;
          -  Adherence to scheduled follow-up is unlikely or life expectancy assumed to be less&#xD;
             than 1 year.&#xD;
&#xD;
          -  Known pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Albert Schweitzer Ziekenhuis</name>
      <address>
        <city>Dordrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Thorax Centrum Twente</investigator_affiliation>
    <investigator_full_name>prof. C. von Birgelen</investigator_full_name>
    <investigator_title>Professor C. von Birgelen</investigator_title>
  </responsible_party>
  <keyword>drug-eluting stent</keyword>
  <keyword>zotarolimus</keyword>
  <keyword>everolimus</keyword>
  <keyword>sirolimus</keyword>
  <keyword>all comers population</keyword>
  <keyword>target vessel failure</keyword>
  <keyword>coronary artery disease</keyword>
  <keyword>durable polymer</keyword>
  <keyword>biodegradable polymer</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>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Coronary Stenosis</mesh_term>
    <mesh_term>Coronary Restenosis</mesh_term>
    <mesh_term>Angina, Unstable</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/NCT01674803
org study id: BIO-RESORT
nct id: NCT01674803
lead sponsor: 
has dmc: Yes
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has
      led to a significant reduction in morbidity. However, the first generation of these devices
      had no positive impact on the mortality after PCI (compared to bare metal stents), which was
      greatly attributed to a somewhat increased incidence of late and very late stent thrombosis.
      Concerns about the role of durable polymers as a potential trigger of inflammation and
      finally adverse events also led to the development of DES with biodegradable coatings, which
      leave after degradation of the coating only a bare metal stent in the vessel wall that does
      not induce an inflammatory response. While such biodegradable polymer DES are increasingly
      used in clinical practice, there is no data available from head-to-head comparisons between
      biodegradable and contemporary third generation durable polymer DES.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Target vessel failure (TVF)
time frame: 1 year
description: Target vessel failure is a combined endpoint of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization.
measure: Target lesion failure (TLF)
time frame: 1 year
description: Target lesion failure is a combined endpoint of cardiac death, target vessel related myocardial infarction, and clinically driven target lesion revascularization
arm group label: Orsiro
arm group type: Active Comparator
arm group label: Synergy
arm group type: Active Comparator
arm group label: Resolute Integrity
arm group type: Active Comparator
intervention type: Device
intervention name: Orsiro
description: biodegradable polymer sirolimus eluting stent
arm group label: Orsiro
intervention type: Device
intervention name: Synergy
description: biodegradable polymer everolimus eluting stent
arm group label: Synergy
intervention type: Device
intervention name: Resolute Integrity
description: durable polymer zotarolimus-eluting stent
arm group label: Resolute Integrity
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Thorax Centrum Twente
investigator full name: prof. C. von Birgelen
investigator title: Professor C. von Birgelen
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: Angina Pectoris
mesh term: Coronary Stenosis
mesh term: Coronary Restenosis
mesh term: Angina, Unstable