<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/NCT03008772</url>
  </required_header>
  <id_info>
    <org_study_id>REWARDS-ISR</org_study_id>
    <nct_id>NCT03008772</nct_id>
  </id_info>
  <brief_title>REWARDS- In-stent Restenosis</brief_title>
  <official_title>REWARDS-In-stent Restenosis</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>
      To define the long-term incidence and frequency of ISR follow DES implantation. Compare the&#xD;
      clinical presentation, treatment and intervention success among de novo coronary artery&#xD;
      stenosis and DES ISR.&#xD;
&#xD;
      Compare short- and long-term outcomes of de novo coronary artery stenosis and DES ISR,&#xD;
      assessed by incidence of mortality, MACE, MI, and TLR/TVR at index hospitalization, 30 days,&#xD;
      6 months, 1 year, 3 years, and 5 years, if available.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Drug-eluting coronary stents (DES) significantly reduced the rate of neointimal hyperplasia&#xD;
      and in-stent restenosis (ISR) compared to bare metal stents (BMS) for the treatment of&#xD;
      coronary artery disease. In addition, the continued evolution in scaffold and polymer design&#xD;
      with concomitant improvements in antiplatelet therapy has improved the rates of late and very&#xD;
      late stent thrombosis. However, despite novel metal scaffold technology, increasing operator&#xD;
      experience, and improvement in adjunctive implantation techniques, the incidence of ISR in&#xD;
      durable-polymer DES remains a problem, with 1-year rates as high as 12 to 15%.&#xD;
&#xD;
      The outcomes associated with ISR highlight the fact that this is by no means a benign process&#xD;
      and studies report MI rates as high as 19.4% with one study demonstrating a total rate of&#xD;
      death or nonfatal MI of 3.5%. In addition, ISR presenting as acute coronary syndrome (ACS)&#xD;
      has an independent effect on major adverse cardiac events. The emergence of fully&#xD;
      bioresorbable vascular scaffolds (BVS) has provided an exciting alternative to combat the&#xD;
      long-term structural and functional effects on the coronary vessel seen with implantation of&#xD;
      a permanent metal scaffold, regardless of the drug coating. Initial studies have demonstrated&#xD;
      the non-inferiority of BVS compared to contemporary DES in regards to death, MI, and MACE. In&#xD;
      addition, intravascular imaging has confirmed complete resorbtion of the BVS by 3 years time.&#xD;
      The long-term benefits of such technology have yet to be fully assessed. However, based on&#xD;
      literature outlining the complicated course of ISR in short-term and that seen in the bare&#xD;
      metal stent era, it is projected that complete resorbtion of the vascular scaffold should&#xD;
      improve long-term outcomes of patients with ischemic heart disease.&#xD;
&#xD;
      Currently, the clinical presentation, incidence, and outcomes of ISR in contemporary DES are&#xD;
      not completely understood. The goal of this particular study is to retrospectively evaluate&#xD;
      the long-term impact of ISR over a 10-year period in current contemporary DES. The data can&#xD;
      be compared to de novo coronary artery lesions with similar characteristics and complexity to&#xD;
      highlight the significant differences in the clinical course of each disease. Ultimately, the&#xD;
      investigators will hopefully demonstrate the need for improvement in this arena, which the&#xD;
      BVS will potentially provide.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not funded&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 2018</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2023</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>Other</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Rate of Instent Restenosis</measure>
    <time_frame>Up to 5 years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>In-Stent Coronary Artery Restenosis</condition>
  <arm_group>
    <arm_group_label>PCI with Commercially available DES</arm_group_label>
    <description>Patients who have undergone PCI and received a commercially available drug eluting stent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stent Types</arm_group_label>
    <description>the stent types for angina classification at follow up</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All study subjects will be identified retrospectively. Patients who have undergone PCI and&#xD;
        received a commercially available drug eluting stent as listed above. These patients will&#xD;
        be compared between the stent types for angina classification at follow up.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients, male or female, &gt; 18 years of age,&#xD;
&#xD;
          -  Patients who received at least one (1) commercially available Drug Eluting Stent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        none&#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>MedStar 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>October 2020</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 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>Coronary Restenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03008772
org study id: REWARDS-ISR
nct id: NCT03008772
lead sponsor: 
has dmc: No
To define the long-term incidence and frequency of ISR follow DES implantation. Compare the
      clinical presentation, treatment and intervention success among de novo coronary artery
      stenosis and DES ISR.

      Compare short- and long-term outcomes of de novo coronary artery stenosis and DES ISR,
      assessed by incidence of mortality, MACE, MI, and TLR/TVR at index hospitalization, 30 days,
      6 months, 1 year, 3 years, and 5 years, if available.
Drug-eluting coronary stents (DES) significantly reduced the rate of neointimal hyperplasia
      and in-stent restenosis (ISR) compared to bare metal stents (BMS) for the treatment of
      coronary artery disease. In addition, the continued evolution in scaffold and polymer design
      with concomitant improvements in antiplatelet therapy has improved the rates of late and very
      late stent thrombosis. However, despite novel metal scaffold technology, increasing operator
      experience, and improvement in adjunctive implantation techniques, the incidence of ISR in
      durable-polymer DES remains a problem, with 1-year rates as high as 12 to 15%.

      The outcomes associated with ISR highlight the fact that this is by no means a benign process
      and studies report MI rates as high as 19.4% with one study demonstrating a total rate of
      death or nonfatal MI of 3.5%. In addition, ISR presenting as acute coronary syndrome (ACS)
      has an independent effect on major adverse cardiac events. The emergence of fully
      bioresorbable vascular scaffolds (BVS) has provided an exciting alternative to combat the
      long-term structural and functional effects on the coronary vessel seen with implantation of
      a permanent metal scaffold, regardless of the drug coating. Initial studies have demonstrated
      the non-inferiority of BVS compared to contemporary DES in regards to death, MI, and MACE. In
      addition, intravascular imaging has confirmed complete resorbtion of the BVS by 3 years time.
      The long-term benefits of such technology have yet to be fully assessed. However, based on
      literature outlining the complicated course of ISR in short-term and that seen in the bare
      metal stent era, it is projected that complete resorbtion of the vascular scaffold should
      improve long-term outcomes of patients with ischemic heart disease.

      Currently, the clinical presentation, incidence, and outcomes of ISR in contemporary DES are
      not completely understood. The goal of this particular study is to retrospectively evaluate
      the long-term impact of ISR over a 10-year period in current contemporary DES. The data can
      be compared to de novo coronary artery lesions with similar characteristics and complexity to
      highlight the significant differences in the clinical course of each disease. Ultimately, the
      investigators will hopefully demonstrate the need for improvement in this arena, which the
      BVS will potentially provide.
observational model: Cohort
time perspective: Other
measure: Rate of Instent Restenosis
time frame: Up to 5 years
arm group label: PCI with Commercially available DES
description: Patients who have undergone PCI and received a commercially available drug eluting stent
arm group label: Stent Types
description: the stent types for angina classification at follow up
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 Restenosis
sharing ipd: No