<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/NCT02192840</url>
  </required_header>
  <id_info>
    <org_study_id>2.0</org_study_id>
    <nct_id>NCT02192840</nct_id>
  </id_info>
  <brief_title>POLish Bifurcation Optimal Stenting Study</brief_title>
  <acronym>POLBOS</acronym>
  <official_title>Regular DES Versus BiOSS Expert® Stent in Coronary Bifurcation Treatment - Randomized, Multicenter, Open-label, Controlled POLBOS I (POLish Bifurcation Optimal Stenting) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University National Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary&#xD;
      interventions (PCI) and are associated with higher rates of periprocedural complications as&#xD;
      well as higher rates of in-stent restenosis and stent thrombosis. Therefore the optimal&#xD;
      approach to coronary bifurcations treatment is still a subject of debate, especially when the&#xD;
      side branch is large, not easily accessible and narrowed by a long lesion. One of the&#xD;
      proposed alternatives are dedicated bifurcation stents (DBS). However, there is large&#xD;
      scarcity of randomized trials with DBS.&#xD;
&#xD;
      The aim of POLBOS I (POLish Bifurcation Optimal Stenting) study was to compare two&#xD;
      intervention strategies for bifurcation treatment: provisional T-stenting (PTS) with any&#xD;
      regular drug-eluting stent (rDES), the best treatment strategy at the moment, with stenting&#xD;
      of bifurcation lesions with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert®&#xD;
      (Balton, PL).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MACE</measure>
    <time_frame>12 months</time_frame>
    <description>Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) with or without ST-segment elevation and need for repeated revascularization of the target lesion (TLR).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cardiac death</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>all-cause death</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion revascularization</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel revascularization</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial infarction</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>late lumen loss</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">243</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>rDES Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Regular drug-eluting stent implantation, one of the following:&#xD;
Device: LucChopin (Balton, Poland) Device: Prolim (Balton, Poland) Device: Xience Pro (Abott Vascular) Device: Biomatrix (Biosensors) Device: Promus (Boston Scientific) Device: Cypher (Cordis) Device: Taxus (Boston Scientific) Device: Coroflex Please (BBraun) Device: Resolute Integrity (Medtronic)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BiOSS Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>New dedicated bifurcation stent BiOSS Expert (Balton, Warsaw, Poland) implantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Coronary angioplasty with stent implantation</intervention_name>
    <description>Coronary angioplasty in bifurcation lesion with drug-eluting stent implantation: BiOSS or regular DES (rDES)</description>
    <arm_group_label>BiOSS Group</arm_group_label>
    <arm_group_label>rDES Group</arm_group_label>
    <other_name>Device: LucChopin (Balton, Poland)</other_name>
    <other_name>Device: Prolim (Balton, Poland)</other_name>
    <other_name>Device: Xience Pro (Abott Vascular)</other_name>
    <other_name>Device: Biomatrix (Biosensors)</other_name>
    <other_name>Device: Promus (Boston Scientific)</other_name>
    <other_name>Device: Cypher (Cordis)</other_name>
    <other_name>Device: Taxus (Boston Scientific)</other_name>
    <other_name>Device: Coroflex Please (BBraun)</other_name>
    <other_name>Device: Resolute Integrity (Medtronic)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject able to verbally confirm understandings of risks, benefits of receiving PCI&#xD;
             for true bifurcation lesions, and he/she or his/her legally authorized representative&#xD;
             provides written informed consent prior to any study related procedure.&#xD;
&#xD;
          -  Target main branch lesion(s) located in a native coronary artery with diameter of ≥&#xD;
             2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery&#xD;
             with diameter of ≥ 2.0 mm.&#xD;
&#xD;
          -  Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  STEMI&#xD;
&#xD;
          -  Non-cardiac co-morbid conditions are present with life expectancy &lt;1 year or that may&#xD;
             result in protocol non-compliance (per site investigator's medical judgment).&#xD;
&#xD;
          -  Subjects who refuse to give informed consent.&#xD;
&#xD;
          -  Subjects with LVEF&lt;30%&#xD;
&#xD;
          -  Subjects with moderate or severe degree valvular heart disease or primary&#xD;
             cardiomyopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert J Gil, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Invasive Cardiology Central Clinical Hospital of the Ministry of Interior</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. doi: 10.1016/j.jacc.2005.05.080. Epub 2005 Sep 28.</citation>
    <PMID>16226167</PMID>
  </reference>
  <reference>
    <citation>Vassilev D, Gil R. Clinical verification of a theory for predicting side branch stenosis after main vessel stenting in coronary bifurcation lesions. J Interv Cardiol. 2008 Dec;21(6):493-503. doi: 10.1111/j.1540-8183.2008.00400.x. Epub 2008 Oct 21.</citation>
    <PMID>18973506</PMID>
  </reference>
  <reference>
    <citation>Gil RJ, Vassilev D, Formuszewicz R, Rusicka-Piekarz T, Doganov A. The carina angle-new geometrical parameter associated with periprocedural side branch compromise and the long-term results in coronary bifurcation lesions with main vessel stenting only. J Interv Cardiol. 2009 Dec;22(6):E1-E10. doi: 10.1111/j.1540-8183.2009.00492.x. Epub 2009 Aug 20.</citation>
    <PMID>19702678</PMID>
  </reference>
  <reference>
    <citation>Vassilev D, Gil R, Kwan T, Nguyen T, Nanjundappa A, Doganov A. Extension distance mismatch--an unrecognized factor for suboptimal side branch ostial coverage in bifurcation lesion stenting. J Interv Cardiol. 2010 Aug;23(4):305-18. doi: 10.1111/j.1540-8183.2010.00574.x. Epub 2010 Jul 19.</citation>
    <PMID>20642477</PMID>
  </reference>
  <reference>
    <citation>Gil RJ, Vassilev D, Michalek A, Kern A, Formuszewicz R, Dobrzycki S, Wojcik J, Lesiak M, Kardaszewicz P, Lekston A. Dedicated paclitaxel-eluting bifurcation stent BiOSS(R) (bifurcation optimisation stent system): 12-month results from a prospective registry of consecutive all-comers population. EuroIntervention. 2012 Jul 20;8(3):316-24. doi: 10.4244/EIJV8I3A50.</citation>
    <PMID>22829507</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland</investigator_affiliation>
    <investigator_full_name>Jacek Bil</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>provisional T stenting</keyword>
  <keyword>dedicated bifurcation stent</keyword>
  <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/NCT02192840
org study id: 2.0
nct id: NCT02192840
lead sponsor: 
collaborator: 
has dmc: Yes
Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary
      interventions (PCI) and are associated with higher rates of periprocedural complications as
      well as higher rates of in-stent restenosis and stent thrombosis. Therefore the optimal
      approach to coronary bifurcations treatment is still a subject of debate, especially when the
      side branch is large, not easily accessible and narrowed by a long lesion. One of the
      proposed alternatives are dedicated bifurcation stents (DBS). However, there is large
      scarcity of randomized trials with DBS.

      The aim of POLBOS I (POLish Bifurcation Optimal Stenting) study was to compare two
      intervention strategies for bifurcation treatment: provisional T-stenting (PTS) with any
      regular drug-eluting stent (rDES), the best treatment strategy at the moment, with stenting
      of bifurcation lesions with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert®
      (Balton, PL).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MACE
time frame: 12 months
description: Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) with or without ST-segment elevation and need for repeated revascularization of the target lesion (TLR).
measure: cardiac death
time frame: 12 months
measure: all-cause death
time frame: 12 months
measure: Target lesion revascularization
time frame: 12 months
measure: Target vessel revascularization
time frame: 12 months
measure: myocardial infarction
time frame: 12 months
measure: late lumen loss
time frame: 12 months
arm group label: rDES Group
arm group type: Active Comparator
description: Regular drug-eluting stent implantation, one of the following:
Device: LucChopin (Balton, Poland) Device: Prolim (Balton, Poland) Device: Xience Pro (Abott Vascular) Device: Biomatrix (Biosensors) Device: Promus (Boston Scientific) Device: Cypher (Cordis) Device: Taxus (Boston Scientific) Device: Coroflex Please (BBraun) Device: Resolute Integrity (Medtronic)
arm group label: BiOSS Group
arm group type: Experimental
description: New dedicated bifurcation stent BiOSS Expert (Balton, Warsaw, Poland) implantation
intervention type: Procedure
intervention name: Coronary angioplasty with stent implantation
description: Coronary angioplasty in bifurcation lesion with drug-eluting stent implantation: BiOSS or regular DES (rDES)
arm group label: BiOSS Group
arm group label: rDES Group
other name: Device: LucChopin (Balton, Poland)
other name: Device: Prolim (Balton, Poland)
other name: Device: Xience Pro (Abott Vascular)
other name: Device: Biomatrix (Biosensors)
other name: Device: Promus (Boston Scientific)
other name: Device: Cypher (Cordis)
other name: Device: Taxus (Boston Scientific)
other name: Device: Coroflex Please (BBraun)
other name: Device: Resolute Integrity (Medtronic)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Robert J Gil, MD, PhD
role: Principal Investigator
affiliation: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
facility: 
country: Poland
citation: Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. doi: 10.1016/j.jacc.2005.05.080. Epub 2005 Sep 28.
PMID: 16226167
citation: Vassilev D, Gil R. Clinical verification of a theory for predicting side branch stenosis after main vessel stenting in coronary bifurcation lesions. J Interv Cardiol. 2008 Dec;21(6):493-503. doi: 10.1111/j.1540-8183.2008.00400.x. Epub 2008 Oct 21.
PMID: 18973506
citation: Gil RJ, Vassilev D, Formuszewicz R, Rusicka-Piekarz T, Doganov A. The carina angle-new geometrical parameter associated with periprocedural side branch compromise and the long-term results in coronary bifurcation lesions with main vessel stenting only. J Interv Cardiol. 2009 Dec;22(6):E1-E10. doi: 10.1111/j.1540-8183.2009.00492.x. Epub 2009 Aug 20.
PMID: 19702678
citation: Vassilev D, Gil R, Kwan T, Nguyen T, Nanjundappa A, Doganov A. Extension distance mismatch--an unrecognized factor for suboptimal side branch ostial coverage in bifurcation lesion stenting. J Interv Cardiol. 2010 Aug;23(4):305-18. doi: 10.1111/j.1540-8183.2010.00574.x. Epub 2010 Jul 19.
PMID: 20642477
citation: Gil RJ, Vassilev D, Michalek A, Kern A, Formuszewicz R, Dobrzycki S, Wojcik J, Lesiak M, Kardaszewicz P, Lekston A. Dedicated paclitaxel-eluting bifurcation stent BiOSS(R) (bifurcation optimisation stent system): 12-month results from a prospective registry of consecutive all-comers population. EuroIntervention. 2012 Jul 20;8(3):316-24. doi: 10.4244/EIJV8I3A50.
PMID: 22829507
responsible party type: Principal Investigator
investigator affiliation: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
investigator full name: Jacek Bil
investigator title: MD, PhD
mesh term: Coronary Artery Disease