<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/NCT02247492</url>
  </required_header>
  <id_info>
    <org_study_id>G1406</org_study_id>
    <nct_id>NCT02247492</nct_id>
  </id_info>
  <brief_title>BIOFLOW-III VIP Russia 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 and Vulnerable Inflammation Parameter Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biotronik Russia</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biotronik Russia</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). Along with it, an explanatory (hypothesis-finding) problem will be&#xD;
      investigated, whether the patient's body inflammation status correlates with the clinical&#xD;
      outcome.&#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;
&#xD;
      Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the&#xD;
      patient's body inflammation status correlates with the clinical outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 14, 2017</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>36 Months</target_duration>
  <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>Target Lesion Failure (TLF)</measure>
    <time_frame>6 and 36 months</time_frame>
    <description>Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Vessel Revascularization (TVR)</measure>
    <time_frame>6 and 36 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 36 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, 12 and 36 months</time_frame>
    <description>Definite, Probable and Possible Stent Thrombosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Device Success</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 1 day</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 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.&#xD;
In case of multiple lesions treatment, all treated lesions must meet the clinical procedural success.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vulnerable Inflammation Parameter (VIP)</measure>
    <time_frame>up to 36 months</time_frame>
    <description>VIP registered ad Endotoxin concentration in patients blood serum</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Coronary Artery Diseases</condition>
  <arm_group>
    <arm_group_label>Orsiro</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects requiring coronary revascularization with Drug Eluting Stents (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&#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>Evgeny Kretov, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Novosibirsk Research Institute for Circulation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ildar Khassanov, Dr.</last_name>
    <phone>+49 9131 852 56 34</phone>
    <email>ildar.khassanov@biotronik.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ural Institute of Cardiology</name>
      <address>
        <city>Ekaterinburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marina Freidlin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Research Institute for Complex Problems of Cardiovascular Diseases</name>
      <address>
        <city>Kemerovo</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gonyukov, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital</name>
      <address>
        <city>Nizhniy Novgorod</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonina Bogush, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Novosibirsk Scientific Research Institute of Circulation Pathology</name>
      <address>
        <city>Novosibirsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evgeniy Kretov</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>City Emergency Clinical Hospital of Rostov-on-Don</name>
      <address>
        <city>Rostov-on-Don</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander Ponomarev, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>North-West Federal Medical Research Center named after V.A. Almazov</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexey Yakovlev</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institute of Cardiology, Tomsk Medical Research</name>
      <address>
        <city>Tomsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sergey Popov</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>July 19, 2018</last_update_submitted>
  <last_update_submitted_qc>July 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>International</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>Percutaneous Coronary Intervention (PCI)</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 (CTO</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/NCT02247492
org study id: G1406
nct id: NCT02247492
lead sponsor: 
has dmc: No
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with
      Drug Eluting Stents (DES). Along with it, an explanatory (hypothesis-finding) problem will be
      investigated, whether the patient's body inflammation status correlates with the clinical
      outcome.
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.

      Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the
      patient's body inflammation status correlates with the clinical outcome.
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: Target Lesion Failure (TLF)
time frame: 6 and 36 months
description: Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)
measure: Target Vessel Revascularization (TVR)
time frame: 6 and 36 months
description: Any repeat revascularization of the target vessel.
measure: Target Lesion Revascularization (TLR)
time frame: 6 and 36 months
description: Defined as any repeat revascularization of the target lesion.
measure: Stent Thrombosis
time frame: 6, 12 and 36 months
description: Definite, Probable and Possible Stent Thrombosis
measure: Clinical Device Success
time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
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 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.
In case of multiple lesions treatment, all treated lesions must meet the clinical procedural success.
measure: Vulnerable Inflammation Parameter (VIP)
time frame: up to 36 months
description: VIP registered ad Endotoxin concentration in patients blood serum
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: Evgeny Kretov, Dr.
role: Principal Investigator
affiliation: Novosibirsk Research Institute for Circulation
last name: Ildar Khassanov, Dr.
phone: +49 9131 852 56 34
email: ildar.khassanov@biotronik.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease