<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/NCT02257710</url>
  </required_header>
  <id_info>
    <org_study_id>G1402</org_study_id>
    <nct_id>NCT02257710</nct_id>
  </id_info>
  <brief_title>BIOFLOW-III UK Satellite Registry Orsiro Stent System</brief_title>
  <official_title>BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III United Kingdom Satellite</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biotronik UK Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biotronik UK Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with&#xD;
      Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal&#xD;
      Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to&#xD;
      long-term complications range from rather immediate elastic coil or vessel contraction to&#xD;
      longer processes like smooth muscle cell proliferation and excessive production of extra&#xD;
      cellular matrix, thrombus formation and atherosclerotic changes like restenosis or&#xD;
      angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to&#xD;
      50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),&#xD;
      designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis&#xD;
      rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS&#xD;
      substantially reduced the incidence of abrupt artery closure, but restenosis still occurred&#xD;
      in about 20 to 40% of cases, necessitating repeat procedures.&#xD;
&#xD;
      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by&#xD;
      adding an antiproliferative drug (directly immobilized on the stent surface or released from&#xD;
      a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly&#xD;
      reduced the incidence of restenosis and resulted in better safety profile as compared to BMS&#xD;
      with systemic drug administration. These advantages and a lower cost compared to surgical&#xD;
      interventions has made DES an attractive option to treat coronary artery disease.&#xD;
&#xD;
      Therefore this observational registry has been designed for the clinical evaluation of the&#xD;
      ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and&#xD;
      collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting&#xD;
      Stent System in an all-comers patient population in daily clinical practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Target Lesion Failure (TLF)</measure>
    <time_frame>12 months</time_frame>
    <description>Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TLF</measure>
    <time_frame>6 months</time_frame>
    <description>Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Vessel Revascularization (TVR)</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Any repeat revascularization of the target vessel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Revascularization (TLR)</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Defined as any repeat revascularization of the target lesion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Thrombosis</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Definite, Probable and Possible Stent Thrombosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Device Success</measure>
    <time_frame>up to seven days</time_frame>
    <description>Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without use of a device outside the assigned treatment strategy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Procedural success</measure>
    <time_frame>up to seven days</time_frame>
    <description>Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event during the hospital stay to a maximum of the first seven days post index procedure.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Coronary Artery Diseases</condition>
  <arm_group>
    <arm_group_label>Orsiro</arm_group_label>
    <description>All subjects requiring coronary revascularization with Drug Eluting Stents (DES)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Orsiro</intervention_name>
    <arm_group_label>Orsiro</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        subjects from an all-comers patient population with all subjects requiring coronary&#xD;
        revascularization with a Drug Eluting Stent (DES).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic coronary artery disease&#xD;
&#xD;
          -  Subject signed informed consent for data release&#xD;
&#xD;
          -  Subject is geographically stable and willing to participate at all follow up&#xD;
             assessments&#xD;
&#xD;
          -  Subject is ≥ 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject did not sign informed consent for data release&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other&#xD;
             anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or&#xD;
             contrast media&#xD;
&#xD;
          -  Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be&#xD;
             maintained&#xD;
&#xD;
          -  Currently participating in another study and primary endpoint not reached yet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Mahmoudi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Peter's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marcus Knott</last_name>
    <phone>+44 (0) 7970084632</phone>
    <email>marcus.knott@biotronik.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Royal Sussex County Hospital</name>
      <address>
        <city>Brighton</city>
        <state>East-Sussex</state>
        <zip>BN2 5BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Hildick-Smith, MD</last_name>
      <phone>+441273696955</phone>
      <phone_ext>4049</phone_ext>
    </contact>
    <investigator>
      <last_name>David Hildick-Smith, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St Peter's Hospital</name>
      <address>
        <city>Chertsey</city>
        <state>Surrey</state>
        <zip>KT16 0PZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Mahmoudi, MD</last_name>
      <phone>+44 1932 872000</phone>
    </contact>
    <investigator>
      <last_name>Michael Mahmoudi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Mahmoudi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospital</name>
      <address>
        <city>Truro</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Trevor Johnston, Dr.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>national</keyword>
  <keyword>Multicenter</keyword>
  <keyword>Observational registry</keyword>
  <keyword>Orsiro Drug Eluting Stent (DES)</keyword>
  <keyword>Stenting</keyword>
  <keyword>Treatment of coronary artery disease</keyword>
  <keyword>Coronary revascularization</keyword>
  <keyword>Coronary Intervention</keyword>
  <keyword>STEMI</keyword>
  <keyword>NSTEMI</keyword>
  <keyword>Ischemia</keyword>
  <keyword>Angina</keyword>
  <keyword>Acute Myocardial Infarction (AMI)</keyword>
  <keyword>Small Vessels</keyword>
  <keyword>Chronic Total Occlusion</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>
  </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/NCT02257710
org study id: G1402
nct id: NCT02257710
lead sponsor: 
has dmc: No
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with
      Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal
      Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to
      long-term complications range from rather immediate elastic coil or vessel contraction to
      longer processes like smooth muscle cell proliferation and excessive production of extra
      cellular matrix, thrombus formation and atherosclerotic changes like restenosis or
      angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to
      50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),
      designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis
      rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS
      substantially reduced the incidence of abrupt artery closure, but restenosis still occurred
      in about 20 to 40% of cases, necessitating repeat procedures.

      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by
      adding an antiproliferative drug (directly immobilized on the stent surface or released from
      a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly
      reduced the incidence of restenosis and resulted in better safety profile as compared to BMS
      with systemic drug administration. These advantages and a lower cost compared to surgical
      interventions has made DES an attractive option to treat coronary artery disease.

      Therefore this observational registry has been designed for the clinical evaluation of the
      ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and
      collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting
      Stent System in an all-comers patient population in daily clinical practice.
observational model: Other
time perspective: Prospective
measure: Target Lesion Failure (TLF)
time frame: 12 months
description: Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR)
measure: TLF
time frame: 6 months
description: Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR)
measure: Target Vessel Revascularization (TVR)
time frame: 6 and 12 months
description: Any repeat revascularization of the target vessel.
measure: Target Lesion Revascularization (TLR)
time frame: 6 and 12 months
description: Defined as any repeat revascularization of the target lesion.
measure: Stent Thrombosis
time frame: 6 and 12 months
description: Definite, Probable and Possible Stent Thrombosis
measure: Clinical Device Success
time frame: up to seven days
description: Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without use of a device outside the assigned treatment strategy.
measure: Clinical Procedural success
time frame: up to seven days
description: Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event during the hospital stay to a maximum of the first seven days post index procedure.
arm group label: Orsiro
description: All subjects requiring coronary revascularization with Drug Eluting Stents (DES)
intervention type: Device
intervention name: Orsiro
arm group label: Orsiro
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Mahmoudi, MD
role: Principal Investigator
affiliation: St. Peter's Hospital
last name: Marcus Knott
phone: +44 (0) 7970084632
email: marcus.knott@biotronik.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease