<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/NCT04475380</url>
  </required_header>
  <id_info>
    <org_study_id>COASTLINE</org_study_id>
    <nct_id>NCT04475380</nct_id>
  </id_info>
  <brief_title>Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents</brief_title>
  <official_title>Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents (COASTLINE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Foundation of Cardiovascular Research and Education Enschede</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Foundation of Cardiovascular Research and Education Enschede</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Drug eluting stents (DES) are widely used for treatment of coronary artery lesions. The&#xD;
      Xience Sierra stent has a refined design of the metal stent backbone and is used in patients&#xD;
      with various clinical syndromes and in different lesions. Clinical outcome of patients with&#xD;
      previously unknown (silent) diabetes and prediabetes is of increasing interest since the&#xD;
      latter group has recently shown to be associated with a significant risk of adverse&#xD;
      cardiovascular events after treatment with contemporary DES. Outcome data in a population of&#xD;
      high-risk all-comer patients, including many patients with diabetes mellitus and prediabetes,&#xD;
      would be of great interest, but such data are not available yet. In addition, there is a lack&#xD;
      of data in a general all-comer population. Therefore, the COASTLINE study will primarily&#xD;
      assess the safety and efficacy of the Xience Sierra stent in a general all-comer population&#xD;
      as well as a high-risk all-comer population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 21, 2018</start_date>
  <completion_date type="Anticipated">April 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Target vessel failure (TVF) at 1-year follow up in complex all-comers</measure>
    <time_frame>1 year</time_frame>
    <description>TVF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target vessel revascularization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Target lesion failure (TLF) at 2-year follow up in all-comers</measure>
    <time_frame>2 year</time_frame>
    <description>TLF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target lesion revascularization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TVF at 2 year follow up</measure>
    <time_frame>2 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>up to 3 year</time_frame>
    <description>any/cardiac/non-cardiac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>up to 3 year</time_frame>
    <description>target vessel related/any/periprocedural</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically indicated target vessel revascularization</measure>
    <time_frame>up to 3 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically indicated target lesion revascularization</measure>
    <time_frame>up to 3 year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1757</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>All-comer patients requiring PCI</arm_group_label>
    <description>All-comer patients requiring percutaneous coronary intervention (PCI) for the treatment of significant coronary artery of bypass graft lesions that are suitable for treatment with Xience Sierra DES</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous coronary intervention</intervention_name>
    <description>PCI for treatment of coronary or bypass graft lesions</description>
    <arm_group_label>All-comer patients requiring PCI</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All-comers. Patients for elective PCI or acute PCI&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years&#xD;
&#xD;
          -  requiring PCI and treated with Xience Sierra&#xD;
&#xD;
          -  capable of providing informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known intolerance to components of the study DES or antithrombotic/anticoagulant&#xD;
             therapy&#xD;
&#xD;
          -  planned elective surgery necessitating interruption of dual antiplatelet therapy&#xD;
             (DAPT) &lt; 3 months&#xD;
&#xD;
          -  patient is known to be pregnant, unlikely to adhere to follow-up or expected live &lt; 1&#xD;
             year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Haga Ziekenhuis</name>
      <address>
        <city>Den Haag</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thoraxcentrum Twente</name>
      <address>
        <city>Enschede</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug-eluting stent</keyword>
  <keyword>Durable polymer</keyword>
  <keyword>Everolimus</keyword>
  <keyword>All comers population</keyword>
  <keyword>High-risk all comers</keyword>
  <keyword>Target vessel failure</keyword>
  <keyword>Coronary artery disease</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/NCT04475380
org study id: COASTLINE
nct id: NCT04475380
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Drug eluting stents (DES) are widely used for treatment of coronary artery lesions. The
      Xience Sierra stent has a refined design of the metal stent backbone and is used in patients
      with various clinical syndromes and in different lesions. Clinical outcome of patients with
      previously unknown (silent) diabetes and prediabetes is of increasing interest since the
      latter group has recently shown to be associated with a significant risk of adverse
      cardiovascular events after treatment with contemporary DES. Outcome data in a population of
      high-risk all-comer patients, including many patients with diabetes mellitus and prediabetes,
      would be of great interest, but such data are not available yet. In addition, there is a lack
      of data in a general all-comer population. Therefore, the COASTLINE study will primarily
      assess the safety and efficacy of the Xience Sierra stent in a general all-comer population
      as well as a high-risk all-comer population.
observational model: Cohort
time perspective: Prospective
measure: Target vessel failure (TVF) at 1-year follow up in complex all-comers
time frame: 1 year
description: TVF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target vessel revascularization.
measure: Target lesion failure (TLF) at 2-year follow up in all-comers
time frame: 2 year
description: TLF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target lesion revascularization.
measure: TVF at 2 year follow up
time frame: 2 year
measure: Death
time frame: up to 3 year
description: any/cardiac/non-cardiac
measure: Myocardial infarction
time frame: up to 3 year
description: target vessel related/any/periprocedural
measure: Clinically indicated target vessel revascularization
time frame: up to 3 year
measure: Clinically indicated target lesion revascularization
time frame: up to 3 year
arm group label: All-comer patients requiring PCI
description: All-comer patients requiring percutaneous coronary intervention (PCI) for the treatment of significant coronary artery of bypass graft lesions that are suitable for treatment with Xience Sierra DES
intervention type: Device
intervention name: Percutaneous coronary intervention
description: PCI for treatment of coronary or bypass graft lesions
arm group label: All-comer patients requiring PCI
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
facility: 
country: Netherlands
responsible party type: Sponsor
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