<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/NCT02256527</url>
  </required_header>
  <id_info>
    <org_study_id>REWARDS Premier TLX</org_study_id>
    <nct_id>NCT02256527</nct_id>
  </id_info>
  <brief_title>REWARDS Premier Taxus-Liberte vs Xience V</brief_title>
  <official_title>REWARDS-Premier TLX (Registry Experience at the WAshington Hospital CenteR, DeS - Premier Taxus-Liberte vs Xience V)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medstar Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medstar Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multicenter, retrospective registry to collect baseline, clinical, procedural, in hospital&#xD;
      and 9-12 month follow-up data to compare major adverse cardiac events in patients receiving&#xD;
      Promus Premier drug eluting stent to data already collected from the REWARDS-TLX Registry in&#xD;
      which patients received either the Taxus Liberte or XIENCE V drug eluting stent.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Major adverse cardiac event</measure>
    <time_frame>1 year</time_frame>
    <description>composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">917</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Promus Premier</arm_group_label>
    <description>observational data</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>compare data</description>
    <arm_group_label>Promus Premier</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients male or female, 18 years or older who have undergone percutaneous coronary&#xD;
        intervention with Promus Premier (alone) drug eluting stent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years of age or older&#xD;
&#xD;
          -  Underwent PCI with Promus Premier (alone) DES&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Underwent PCI with a non-Promus Premier DES during the same index procedure&#xD;
&#xD;
          -  Patients not taking, or unable to take, dual antiplatelet therapy (aspirin plus&#xD;
             clopidogrel, prasugrel, or ticagrelor)&#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>Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>July 13, 2016</last_update_submitted>
  <last_update_submitted_qc>July 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2016</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>Coronary Artery Disease</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/NCT02256527
org study id: REWARDS Premier TLX
nct id: NCT02256527
lead sponsor: 
has dmc: No
Multicenter, retrospective registry to collect baseline, clinical, procedural, in hospital
      and 9-12 month follow-up data to compare major adverse cardiac events in patients receiving
      Promus Premier drug eluting stent to data already collected from the REWARDS-TLX Registry in
      which patients received either the Taxus Liberte or XIENCE V drug eluting stent.
observational model: Case-Only
time perspective: Retrospective
measure: Major adverse cardiac event
time frame: 1 year
description: composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization
arm group label: Promus Premier
description: observational data
intervention type: Other
intervention name: Observational
description: compare data
arm group label: Promus Premier
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease