<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/NCT02263313</url>
  </required_header>
  <id_info>
    <org_study_id>UW 14-456 (IRB HKU)</org_study_id>
    <nct_id>NCT02263313</nct_id>
  </id_info>
  <brief_title>EGO-COMBO Clinical End-point Extension Study Beyond 36 Months</brief_title>
  <official_title>Evaluation of Endothelial ProGenitor Cell Capture Sirolimus-Eluting Stent by Optical Coherence Tomography: the COMBO Stent 36-months Clinical End-point Extension Study (EGO-COMBO Clinical End-point Extension Study Beyond 36 Months)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the safety and efficacy of COMBO TM stent beyond 36 months are assessed, in&#xD;
      particular the occurrence of late stent thrombosis and late loss catch-up (restenosis).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Genous Stent (the EPC Capture R-stent, OrbusNeich Medical Inc., Fort Lauderdale, FL) is&#xD;
      commercially available and has been used extensively in standard coronary intervention in the&#xD;
      treatment of more than 200 patients with critical coronary stenoses at Queen Mary Hospital.&#xD;
      The COMBO Stent (OrbusNeich Medical Inc., Fort Lauderdale, FL) is an improved version of the&#xD;
      Genous Stent and is now widely available for clinical use in all Hong Kong hospitals. To&#xD;
      date, more than 300 patients in Queen Mary Hospital have received the COMBO stent as&#xD;
      treatment for their coronary artery disease, and all of them remained stable clinically.&#xD;
&#xD;
      The Genous Stent is a bio-engineered 316L stainless steel coronary stent with a biocompatible&#xD;
      coating having specific CD34 antibody on the inner surface. CD34 is a surface antigen present&#xD;
      on circulating endothelial progenitor cell (EPC). It will be bonded to the CD34 antibody,&#xD;
      resulting in capturing of the EPC onto the stent surface and differentiation into endothelial&#xD;
      layer. Animal model has demonstrated that a functional endothelial layer could be formed as&#xD;
      soon as 24 to 48 hours after Genous stent implantation (1). The HEALING-FIM registry has&#xD;
      shown that Genous stent is clinically safe and effective in the treatment of coronary&#xD;
      stenosis (2). Recent reports have further confirmed its efficacy in patients with acute&#xD;
      coronary syndrome requiring urgent revascularization (3,4).&#xD;
&#xD;
      The COMBO Stent is an improved version of the Genous Stent. The stent delivers a drug called&#xD;
      sirolimus to the treated coronary blood vessel. This stent also incorporates a CD34 antibody&#xD;
      coating that is designed to promote the healing of the treated coronary artery by catching&#xD;
      endothelial progenitor cells from circulating blood as they pass through the stent. These&#xD;
      cells are pro-healing and will help the blood vessel wall to heal over the stent more quickly&#xD;
      and restore normal tissue function in the stented area. The combination of these two&#xD;
      technologies in this new Combo stent is expected to produce even better clinical results,&#xD;
      which are published in the REMEDEE Study.&#xD;
&#xD;
      Pre-clinical animal study has already shown the Combo Stent promoted endothelialization and&#xD;
      reduced neointima formation, as assessed by both optical coherence tomography (OCT) and&#xD;
      histopathology (5). However, such beneficial endothelial coverage as assessed by OCT has&#xD;
      never been documented in human subjects, and has been addressed by previous study protocol:&#xD;
      the EGO Study (IRB: UW 10-256), EGO-COMBO Pilot Study (UW 10-342) and EGO-COMBO angiographic&#xD;
      extension study (UW 12-472). Queen Mary Hospital is currently the single cardiac centre&#xD;
      worldwide with such vast experience in using the COMBO stent for percutaneous coronary&#xD;
      intervention, together with intracoronary OCT to profile the stent's healing progress and&#xD;
      subsequent neo-intimal growth and behaviour.&#xD;
&#xD;
      This current study protocol serves as an extension study to evaluate the long term clinical&#xD;
      safety and efficacy of COMBO stent beyond 36 months post-implantation.&#xD;
&#xD;
      This is a single centre observational study to assess the safety and effectiveness clinical&#xD;
      endpoints of COMBO TM stent beyond 36 months. Clinical notes for all subjects that previously&#xD;
      participated in EGO-COMBO Pilot Study (UW 10-342) will be reviewed for clinical end points&#xD;
      according to the definition of Academic Research Consortium and angina symptoms will be&#xD;
      classified with Canadian Cardiovascular Society Angina Classification.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Major Adverse Cardiac Events (MACE)</measure>
    <time_frame>beyond 36 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>beyond 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>beyond 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Revascularization</measure>
    <time_frame>beyond 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angina Class</measure>
    <time_frame>beyond 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Vessel Failure</measure>
    <time_frame>beyond 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Death</measure>
    <time_frame>beyond 36 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>Coronary Restenosis</condition>
  <arm_group>
    <arm_group_label>EGO-COMBO group</arm_group_label>
    <description>Previously enrolled into EGO-COMBO Pilot study and with combo stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EGO-COMBO group</intervention_name>
    <description>Assess the safety and effectiveness of Combo stent</description>
    <arm_group_label>EGO-COMBO group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This is a single centre observational study to assess the safety and effectiveness clinical&#xD;
        endpoints of COMBO TM stent beyond 36 months. Clinical notes for all subjects that&#xD;
        previously participated in EGO-COMBO Pilot Study (UW 10-342) will be reviewed for clinical&#xD;
        end points according to the definition of Academic Research Consortium and angina symptoms&#xD;
        will be classified with Canadian Cardiovascular Society Angina Classification.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient previously participated in EGO-COMBO Pilot Study (UW 10-342)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient not previously participated in EGO-COMBO Pilot Study (UW 10-342)&#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>Wai Luen Stephen LEE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Univeristy of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Medicine, Queen Mary Hospital, The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Prati F, Cera M, Ramazzotti V, Imola F, Giudice R, Albertucci M. Safety and feasibility of a new non-occlusive technique for facilitated intracoronary optical coherence tomography (OCT) acquisition in various clinical and anatomical scenarios. EuroIntervention. 2007 Nov;3(3):365-70. doi: 10.4244/eijv3i3a66.</citation>
    <PMID>19737719</PMID>
  </results_reference>
  <results_reference>
    <citation>Haude M, Lee SW, Worthley SG, Silber S, Verheye S, Erbs S, Rosli MA, Botelho R, Meredith I, Sim KH, Stella PR, Tan HC, Whitbourn R, Thambar S, Abizaid A, Koh TH, Den Heijer P, Parise H, Cristea E, Maehara A, Mehran R. The REMEDEE trial: a randomized comparison of a combination sirolimus-eluting endothelial progenitor cell capture stent with a paclitaxel-eluting stent. JACC Cardiovasc Interv. 2013 Apr;6(4):334-43. doi: 10.1016/j.jcin.2012.10.018. Epub 2013 Mar 20.</citation>
    <PMID>23523459</PMID>
  </results_reference>
  <results_reference>
    <citation>Yamaguchi T, Terashima M, Akasaka T, Hayashi T, Mizuno K, Muramatsu T, Nakamura M, Nakamura S, Saito S, Takano M, Takayama T, Yoshikawa J, Suzuki T. Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical setting. Am J Cardiol. 2008 Mar 1;101(5):562-7. doi: 10.1016/j.amjcard.2007.09.116. Epub 2008 Jan 10.</citation>
    <PMID>18307999</PMID>
  </results_reference>
  <results_reference>
    <citation>Granada JF, Inami S, Aboodi MS, Tellez A, Milewski K, Wallace-Bradley D, Parker S, Rowland S, Nakazawa G, Vorpahl M, Kolodgie FD, Kaluza GL, Leon MB, Virmani R. Development of a novel prohealing stent designed to deliver sirolimus from a biodegradable abluminal matrix. Circ Cardiovasc Interv. 2010 Jun 1;3(3):257-66. doi: 10.1161/CIRCINTERVENTIONS.109.919936. Epub 2010 May 4.</citation>
    <PMID>20442358</PMID>
  </results_reference>
  <results_reference>
    <citation>Co M, Tay E, Lee CH, Poh KK, Low A, Lim J, Lim IH, Lim YT, Tan HC. Use of endothelial progenitor cell capture stent (Genous Bio-Engineered R Stent) during primary percutaneous coronary intervention in acute myocardial infarction: intermediate- to long-term clinical follow-up. Am Heart J. 2008 Jan;155(1):128-32. doi: 10.1016/j.ahj.2007.08.031. Epub 2007 Nov 26.</citation>
    <PMID>18082503</PMID>
  </results_reference>
  <results_reference>
    <citation>Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.</citation>
    <PMID>17470709</PMID>
  </results_reference>
  <results_reference>
    <citation>Aoki J, Serruys PW, van Beusekom H, Ong AT, McFadden EP, Sianos G, van der Giessen WJ, Regar E, de Feyter PJ, Davis HR, Rowland S, Kutryk MJ. Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry. J Am Coll Cardiol. 2005 May 17;45(10):1574-9. doi: 10.1016/j.jacc.2005.01.048.</citation>
    <PMID>15893169</PMID>
  </results_reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Prof. Stephen Lee</investigator_full_name>
    <investigator_title>Professor and Chief</investigator_title>
  </responsible_party>
  <keyword>Safety and efficacy</keyword>
  <keyword>Combo stent</keyword>
  <keyword>Late loss thrombosis</keyword>
  <keyword>Late loss catch up</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Restenosis</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/NCT02263313
org study id: UW 14-456 (IRB HKU)
nct id: NCT02263313
lead sponsor: 
has dmc: No
In this study, the safety and efficacy of COMBO TM stent beyond 36 months are assessed, in
      particular the occurrence of late stent thrombosis and late loss catch-up (restenosis).
The Genous Stent (the EPC Capture R-stent, OrbusNeich Medical Inc., Fort Lauderdale, FL) is
      commercially available and has been used extensively in standard coronary intervention in the
      treatment of more than 200 patients with critical coronary stenoses at Queen Mary Hospital.
      The COMBO Stent (OrbusNeich Medical Inc., Fort Lauderdale, FL) is an improved version of the
      Genous Stent and is now widely available for clinical use in all Hong Kong hospitals. To
      date, more than 300 patients in Queen Mary Hospital have received the COMBO stent as
      treatment for their coronary artery disease, and all of them remained stable clinically.

      The Genous Stent is a bio-engineered 316L stainless steel coronary stent with a biocompatible
      coating having specific CD34 antibody on the inner surface. CD34 is a surface antigen present
      on circulating endothelial progenitor cell (EPC). It will be bonded to the CD34 antibody,
      resulting in capturing of the EPC onto the stent surface and differentiation into endothelial
      layer. Animal model has demonstrated that a functional endothelial layer could be formed as
      soon as 24 to 48 hours after Genous stent implantation (1). The HEALING-FIM registry has
      shown that Genous stent is clinically safe and effective in the treatment of coronary
      stenosis (2). Recent reports have further confirmed its efficacy in patients with acute
      coronary syndrome requiring urgent revascularization (3,4).

      The COMBO Stent is an improved version of the Genous Stent. The stent delivers a drug called
      sirolimus to the treated coronary blood vessel. This stent also incorporates a CD34 antibody
      coating that is designed to promote the healing of the treated coronary artery by catching
      endothelial progenitor cells from circulating blood as they pass through the stent. These
      cells are pro-healing and will help the blood vessel wall to heal over the stent more quickly
      and restore normal tissue function in the stented area. The combination of these two
      technologies in this new Combo stent is expected to produce even better clinical results,
      which are published in the REMEDEE Study.

      Pre-clinical animal study has already shown the Combo Stent promoted endothelialization and
      reduced neointima formation, as assessed by both optical coherence tomography (OCT) and
      histopathology (5). However, such beneficial endothelial coverage as assessed by OCT has
      never been documented in human subjects, and has been addressed by previous study protocol:
      the EGO Study (IRB: UW 10-256), EGO-COMBO Pilot Study (UW 10-342) and EGO-COMBO angiographic
      extension study (UW 12-472). Queen Mary Hospital is currently the single cardiac centre
      worldwide with such vast experience in using the COMBO stent for percutaneous coronary
      intervention, together with intracoronary OCT to profile the stent's healing progress and
      subsequent neo-intimal growth and behaviour.

      This current study protocol serves as an extension study to evaluate the long term clinical
      safety and efficacy of COMBO stent beyond 36 months post-implantation.

      This is a single centre observational study to assess the safety and effectiveness clinical
      endpoints of COMBO TM stent beyond 36 months. Clinical notes for all subjects that previously
      participated in EGO-COMBO Pilot Study (UW 10-342) will be reviewed for clinical end points
      according to the definition of Academic Research Consortium and angina symptoms will be
      classified with Canadian Cardiovascular Society Angina Classification.
observational model: Cohort
time perspective: Retrospective
measure: Composite Major Adverse Cardiac Events (MACE)
time frame: beyond 36 months
measure: All-cause mortality
time frame: beyond 36 months
measure: Myocardial infarction
time frame: beyond 36 months
measure: Target Lesion Revascularization
time frame: beyond 36 months
measure: Angina Class
time frame: beyond 36 months
measure: Target Vessel Failure
time frame: beyond 36 months
measure: Cardiac Death
time frame: beyond 36 months
arm group label: EGO-COMBO group
description: Previously enrolled into EGO-COMBO Pilot study and with combo stent
intervention type: Other
intervention name: EGO-COMBO group
description: Assess the safety and effectiveness of Combo stent
arm group label: EGO-COMBO group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wai Luen Stephen LEE, MD
role: Principal Investigator
affiliation: The Univeristy of Hong Kong
facility: 
country: China
citation: Prati F, Cera M, Ramazzotti V, Imola F, Giudice R, Albertucci M. Safety and feasibility of a new non-occlusive technique for facilitated intracoronary optical coherence tomography (OCT) acquisition in various clinical and anatomical scenarios. EuroIntervention. 2007 Nov;3(3):365-70. doi: 10.4244/eijv3i3a66.
PMID: 19737719
citation: Haude M, Lee SW, Worthley SG, Silber S, Verheye S, Erbs S, Rosli MA, Botelho R, Meredith I, Sim KH, Stella PR, Tan HC, Whitbourn R, Thambar S, Abizaid A, Koh TH, Den Heijer P, Parise H, Cristea E, Maehara A, Mehran R. The REMEDEE trial: a randomized comparison of a combination sirolimus-eluting endothelial progenitor cell capture stent with a paclitaxel-eluting stent. JACC Cardiovasc Interv. 2013 Apr;6(4):334-43. doi: 10.1016/j.jcin.2012.10.018. Epub 2013 Mar 20.
PMID: 23523459
citation: Yamaguchi T, Terashima M, Akasaka T, Hayashi T, Mizuno K, Muramatsu T, Nakamura M, Nakamura S, Saito S, Takano M, Takayama T, Yoshikawa J, Suzuki T. Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical setting. Am J Cardiol. 2008 Mar 1;101(5):562-7. doi: 10.1016/j.amjcard.2007.09.116. Epub 2008 Jan 10.
PMID: 18307999
citation: Granada JF, Inami S, Aboodi MS, Tellez A, Milewski K, Wallace-Bradley D, Parker S, Rowland S, Nakazawa G, Vorpahl M, Kolodgie FD, Kaluza GL, Leon MB, Virmani R. Development of a novel prohealing stent designed to deliver sirolimus from a biodegradable abluminal matrix. Circ Cardiovasc Interv. 2010 Jun 1;3(3):257-66. doi: 10.1161/CIRCINTERVENTIONS.109.919936. Epub 2010 May 4.
PMID: 20442358
citation: Co M, Tay E, Lee CH, Poh KK, Low A, Lim J, Lim IH, Lim YT, Tan HC. Use of endothelial progenitor cell capture stent (Genous Bio-Engineered R Stent) during primary percutaneous coronary intervention in acute myocardial infarction: intermediate- to long-term clinical follow-up. Am Heart J. 2008 Jan;155(1):128-32. doi: 10.1016/j.ahj.2007.08.031. Epub 2007 Nov 26.
PMID: 18082503
citation: Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.
PMID: 17470709
citation: Aoki J, Serruys PW, van Beusekom H, Ong AT, McFadden EP, Sianos G, van der Giessen WJ, Regar E, de Feyter PJ, Davis HR, Rowland S, Kutryk MJ. Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry. J Am Coll Cardiol. 2005 May 17;45(10):1574-9. doi: 10.1016/j.jacc.2005.01.048.
PMID: 15893169
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Prof. Stephen Lee
investigator title: Professor and Chief
mesh term: Coronary Restenosis