<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/NCT01667003</url>
  </required_header>
  <id_info>
    <org_study_id>G1209</org_study_id>
    <nct_id>NCT01667003</nct_id>
  </id_info>
  <brief_title>BIOFLOW-III Sweden Satellite Registry</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 Sweden</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biotronik ApS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biotronik ApS</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring&#xD;
      coronary revascularization with Drug Eluting Stents (DES).&#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 procedural success. However, the medium to&#xD;
      long-term complications range from rather immediate elastic recoil 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&#xD;
      30%-50%. Such rates of recurrence have serious economic consequences.&#xD;
&#xD;
      Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the&#xD;
      angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and&#xD;
      decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery&#xD;
      closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat&#xD;
      procedures.&#xD;
&#xD;
      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by&#xD;
      adding an antiproliferative drug (directly immobilised 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 a better safety profile as compared to&#xD;
      BMS with systemic drug administration.&#xD;
&#xD;
      These advantages and a lower cost compared to surgical interventions has made DES an&#xD;
      attractive option to treat coronary artery disease. This observational registry is designed&#xD;
      to investigate and collect clinical evidence for the clinical performance and safety of the&#xD;
      Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical&#xD;
      practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Failure (TLF)</measure>
    <time_frame>6 and 12 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 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>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, Possible Stent thrombosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Device Success</measure>
    <time_frame>At time of intervention</time_frame>
    <description>Successful delivery and deployment of the investigational stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple overlapping stents) 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. Standard predilation catheters and post-dilation catheters (if applicable) may be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Procedural Success</measure>
    <time_frame>During the hospital stay to a maximum of the first seven days post index procedure</time_frame>
    <description>Successful delivery and deployment of the investigational stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple overlapping stents, if applicable) and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% of the target lesion as observed by visual estimate without using any adjunctive device* without the occurrence of ischemia-driven major adverse cardiac event (ID-MACE) 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="Actual">406</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Myocardial Ischemia</condition>
  <arm_group>
    <arm_group_label>Orsiro DES</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All-comers patient population with all subjects requiring coronary revascularization with a&#xD;
        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 has 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&#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;
             anticoagulation / antiplatelet therapy required for PCI, stainless steel, Sirolimus or&#xD;
             contrast media&#xD;
&#xD;
          -  Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be&#xD;
             maintained&#xD;
&#xD;
          -  Currently participating in another study and primary endpoint is 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>Ole Froebert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kardiologiska Kliniken</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Falun Lasarett</name>
      <address>
        <city>Falun</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Halmstad Hospital</name>
      <address>
        <city>Halmstad</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsingborg Hospital</name>
      <address>
        <city>Helsingborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralsjukhuset i Karlstad</name>
      <address>
        <city>Karlstad</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hjärtmottagningen</name>
      <address>
        <city>Stockholm</city>
        <zip>11883</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Danderyd University Hospital</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospitals (Huddinge/Solna)</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologiska Kliniken</name>
      <address>
        <city>Örebro</city>
        <zip>701 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</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</keyword>
  <keyword>STEMI</keyword>
  <keyword>NSTEMI</keyword>
  <keyword>Ischemia</keyword>
  <keyword>Angina</keyword>
  <keyword>Subgroups</keyword>
  <keyword>Acute Myocardial Infarction</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Small Vessels</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>Ischemia</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/NCT01667003
org study id: G1209
nct id: NCT01667003
lead sponsor: 
has dmc: No
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring
      coronary revascularization with Drug Eluting Stents (DES).
For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal
      Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to
      long-term complications range from rather immediate elastic recoil 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%-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%-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 immobilised 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 a 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. This observational registry 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), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)
measure: Target Lesion Failure (TLF)
time frame: 6 and 12 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 12 months
description: Any repeat revascularization of the target vessel.
measure: Target Lesion Revascularization (TLR)
time frame: 6 and 12 months
description: Any repeat revascularization of the target lesion.
measure: Stent Thrombosis
time frame: 6 and 12 months
description: Definite, Probable, Possible Stent thrombosis
measure: Clinical Device Success
time frame: At time of intervention
description: Successful delivery and deployment of the investigational stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple overlapping stents) 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. Standard predilation catheters and post-dilation catheters (if applicable) may be used.
measure: Clinical Procedural Success
time frame: During the hospital stay to a maximum of the first seven days post index procedure
description: Successful delivery and deployment of the investigational stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple overlapping stents, if applicable) and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% of the target lesion as observed by visual estimate without using any adjunctive device* without the occurrence of ischemia-driven major adverse cardiac event (ID-MACE) during the hospital stay to a maximum of the first seven days post index procedure.
arm group label: Orsiro DES
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ole Froebert, MD
role: Principal Investigator
affiliation: Kardiologiska Kliniken
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Ischemia