<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/NCT02198300</url>
  </required_header>
  <id_info>
    <org_study_id>2.1</org_study_id>
    <nct_id>NCT02198300</nct_id>
  </id_info>
  <brief_title>DES Versus BiOSS LIM - POLBOS II Study</brief_title>
  <acronym>POLBOS II</acronym>
  <official_title>Regular Drug Eluting Stent Versus Dedicated Bifurcation Sirolimus-eluting Stent BiOSS LIM in Coronary Bifurcation Treatment - Randomized POLBOS II 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>
  </sponsors>
  <source>Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland</source>
  <oversight_info>
    <has_dmc>No</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. Provisional T-stenting&#xD;
      (PTS) is the best treatment strategy at the moment. However, the optimal approach to coronary&#xD;
      bifurcations treatment is still a subject of debate, especially when the side branch is&#xD;
      large, not easily accessible and narrowed by a long lesion. One of the proposed alternatives&#xD;
      are dedicated bifurcation stents (DBS). However, there is large scarcity of randomized trials&#xD;
      with DBS. POLBOS II study is continuation of POLBOS I (POLish Bifurcation Optimal Stenting)&#xD;
      study, in which paclitaxel-eluting stent BiOSS Expert® (Balton, Poland) was assessed. Now&#xD;
      performance of sirolimus-eluting stent BiOSS LIM® (Balton, Poland) is verified.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After signing the informed consent patients were randomly assigned to one of two treatment&#xD;
      strategies: BiOSS LIM® stent implantation or rDES implantation (envelope randomization, 1:1).&#xD;
      If the patient was enrolled to rDES Group there was a second randomization: with or without&#xD;
      final kissing ballooning (FKB). Clinical follow-up was performed with office visits or&#xD;
      telephone contacts at 1 and 12 months after intervention. Adverse events were monitored&#xD;
      throughout the study period. Follow-up coronary angiography was performed at 12 months unless&#xD;
      clinically indicated earlier.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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) and 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>MI</measure>
    <time_frame>12 months</time_frame>
    <description>myocardial infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TLR</measure>
    <time_frame>12 months</time_frame>
    <description>target lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TVR</measure>
    <time_frame>12 months</time_frame>
    <description>target vessel revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LLL</measure>
    <time_frame>12 months</time_frame>
    <description>late lumen loss</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">202</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 in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BiOSS LIM Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BiOSS LIM® stent implantation into coronary lesion within bifurcation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Coronary angioplasty with stent implantation</intervention_name>
    <arm_group_label>BiOSS LIM Group</arm_group_label>
    <arm_group_label>rDES Group</arm_group_label>
    <other_name>device: LucChopin (Balton, Poland)</other_name>
    <other_name>device: Xience (Abbot Vascular)</other_name>
    <other_name>device: Promus (Boston Scientific)</other_name>
    <other_name>device: Resolute Integrity (Medtronic)</other_name>
    <other_name>device: Biomatrix (Biosensors)</other_name>
    <other_name>device: Prolim (Balton, Poland)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dual antipletlet therapy (DAPT)</intervention_name>
    <description>DAPT given to each patient before stent implantation</description>
    <arm_group_label>BiOSS LIM Group</arm_group_label>
    <arm_group_label>rDES Group</arm_group_label>
    <other_name>acetysalicylic acid</other_name>
    <other_name>clopidogrel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stable coronary artery disease (CAD) or non-ST-segment elevation acute coronary&#xD;
             syndrome (NSTE-ACS)&#xD;
&#xD;
          -  age ≥ 18 years old,&#xD;
&#xD;
          -  de novo coronary bifurcation lesion (including unprotected LMS),&#xD;
&#xD;
          -  MV diameter ≥ 2.5 mm and SB diameter ≥ 2.0 mm assessed by visual estimation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ST-elevation myocardial infarction (STEMI),&#xD;
&#xD;
          -  bifurcations with Medina type 0,0,1,&#xD;
&#xD;
          -  serum creatinine level ≥ 2.0 mg/dl,&#xD;
&#xD;
          -  inability to take dual antiplatelet therapy for 12 months,&#xD;
&#xD;
          -  left ejection fraction ≤ 30%&#xD;
&#xD;
          -  lack of an informed consent&#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>Central Clinical Hospital of the Ministry of Interior</name>
      <address>
        <city>Warsaw</city>
        <state>Mazowieckie</state>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Bil J, Gil RJ, Vassilev D, Rzezak J, Kulawik T, Pawlowski T. Dedicated bifurcation paclitaxel-eluting stent BiOSS Expert(R) in the treatment of distal left main stem stenosis. J Interv Cardiol. 2014 Jun;27(3):242-51. doi: 10.1111/joic.12119. Epub 2014 Apr 7.</citation>
    <PMID>24708143</PMID>
  </reference>
  <reference>
    <citation>Vassilev D, Mateev H, Alexandrov A, Stankev M, Rigatelli G, Gil RJ. Stenting below-the-knee bifurcations with dedicated bifurcation stent BiOSS Lim - first in man case report. Cardiovasc Revasc Med. 2014 Apr;15(3):171-7. doi: 10.1016/j.carrev.2013.09.005. Epub 2013 Oct 22.</citation>
    <PMID>24157310</PMID>
  </reference>
  <reference>
    <citation>Gil RJ, Bil J, Michalek A, Vassiliev D, Costa RA. Comparative analysis of lumen enlargement mechanisms achieved with the bifurcation dedicated BiOSS) stent versus classical coronary stent implantations by means of provisional side branch stenting strategy: an intravascular ultrasound study. Int J Cardiovasc Imaging. 2013 Dec;29(8):1667-76. doi: 10.1007/s10554-013-0264-0. Epub 2013 Jul 19.</citation>
    <PMID>23868287</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>
  <reference>
    <citation>Vassilev D, Gil R, Milewski K. Bifurcation Optimisation Stent System (BiOSS Lim) with sirolimus elution: results from porcine coronary artery model. EuroIntervention. 2011 Sep;7(5):614-20. doi: 10.4244/EIJV7I5A98.</citation>
    <PMID>21930466</PMID>
  </reference>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 28, 2015</last_update_submitted>
  <last_update_submitted_qc>July 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2015</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>dedicated bifurcation stent</keyword>
  <keyword>sirolimus eluting stent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clopidogrel</mesh_term>
  </intervention_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/NCT02198300
org study id: 2.1
nct id: NCT02198300
lead sponsor: 
has dmc: No
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. Provisional T-stenting
      (PTS) is the best treatment strategy at the moment. However, 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. POLBOS II study is continuation of POLBOS I (POLish Bifurcation Optimal Stenting)
      study, in which paclitaxel-eluting stent BiOSS Expert® (Balton, Poland) was assessed. Now
      performance of sirolimus-eluting stent BiOSS LIM® (Balton, Poland) is verified.
After signing the informed consent patients were randomly assigned to one of two treatment
      strategies: BiOSS LIM® stent implantation or rDES implantation (envelope randomization, 1:1).
      If the patient was enrolled to rDES Group there was a second randomization: with or without
      final kissing ballooning (FKB). Clinical follow-up was performed with office visits or
      telephone contacts at 1 and 12 months after intervention. Adverse events were monitored
      throughout the study period. Follow-up coronary angiography was performed at 12 months unless
      clinically indicated earlier.
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) and repeated revascularization of the target lesion (TLR)
measure: cardiac death
time frame: 12 months
measure: all-cause death
time frame: 12 months
measure: MI
time frame: 12 months
description: myocardial infarction
measure: TLR
time frame: 12 months
description: target lesion revascularization
measure: TVR
time frame: 12 months
description: target vessel revascularization
measure: LLL
time frame: 12 months
description: late lumen loss
arm group label: rDES Group
arm group type: Active Comparator
description: regular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim
arm group label: BiOSS LIM Group
arm group type: Experimental
description: BiOSS LIM® stent implantation into coronary lesion within bifurcation.
intervention type: Procedure
intervention name: Coronary angioplasty with stent implantation
arm group label: BiOSS LIM Group
arm group label: rDES Group
other name: device: LucChopin (Balton, Poland)
other name: device: Xience (Abbot Vascular)
other name: device: Promus (Boston Scientific)
other name: device: Resolute Integrity (Medtronic)
other name: device: Biomatrix (Biosensors)
other name: device: Prolim (Balton, Poland)
intervention type: Drug
intervention name: Dual antipletlet therapy (DAPT)
description: DAPT given to each patient before stent implantation
arm group label: BiOSS LIM Group
arm group label: rDES Group
other name: acetysalicylic acid
other name: clopidogrel
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: Bil J, Gil RJ, Vassilev D, Rzezak J, Kulawik T, Pawlowski T. Dedicated bifurcation paclitaxel-eluting stent BiOSS Expert(R) in the treatment of distal left main stem stenosis. J Interv Cardiol. 2014 Jun;27(3):242-51. doi: 10.1111/joic.12119. Epub 2014 Apr 7.
PMID: 24708143
citation: Vassilev D, Mateev H, Alexandrov A, Stankev M, Rigatelli G, Gil RJ. Stenting below-the-knee bifurcations with dedicated bifurcation stent BiOSS Lim - first in man case report. Cardiovasc Revasc Med. 2014 Apr;15(3):171-7. doi: 10.1016/j.carrev.2013.09.005. Epub 2013 Oct 22.
PMID: 24157310
citation: Gil RJ, Bil J, Michalek A, Vassiliev D, Costa RA. Comparative analysis of lumen enlargement mechanisms achieved with the bifurcation dedicated BiOSS) stent versus classical coronary stent implantations by means of provisional side branch stenting strategy: an intravascular ultrasound study. Int J Cardiovasc Imaging. 2013 Dec;29(8):1667-76. doi: 10.1007/s10554-013-0264-0. Epub 2013 Jul 19.
PMID: 23868287
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
citation: Vassilev D, Gil R, Milewski K. Bifurcation Optimisation Stent System (BiOSS Lim) with sirolimus elution: results from porcine coronary artery model. EuroIntervention. 2011 Sep;7(5):614-20. doi: 10.4244/EIJV7I5A98.
PMID: 21930466
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
mesh term: Clopidogrel