<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/NCT02986295</url>
  </required_header>
  <id_info>
    <org_study_id>2016-04-059</org_study_id>
    <nct_id>NCT02986295</nct_id>
  </id_info>
  <brief_title>Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent</brief_title>
  <acronym>SMARTDESK-MX</acronym>
  <official_title>Real World Drug-Eluting Stent Prospective, Open, Multi-site, Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent By SMart Angioplastry Research Team (SMARTDESK-MX)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hyeon-Cheol Gwon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Meril Life Sciences Pvt. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Terumo Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with&#xD;
      Xience® stent&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, open, multicenter, and observational study will register and compare Xience®&#xD;
      groups treated in institutions such as the BioMime ™, Ultimaster® group prospectively&#xD;
      registered from June 2016.&#xD;
&#xD;
      The Xience® group has already been registered in the previous study (SMARTDESK-BX), so&#xD;
      BioMimeTM and Ultimaster® only need to be registered. Follow-up will be conducted until&#xD;
      December 2019, and e-CRF will be completed by April 2020.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>The incidence of 1-year target lesion failure</measure>
    <time_frame>1-year</time_frame>
    <description>The incidence of 1-year target lesion failure (combination of cardiac death, target vessel myocardial infarction, and target vessel revascularization).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of 30-day and 2-year target lesion failure</measure>
    <time_frame>30-day and 2-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of 30-day, 1-year, and 2-year deaths</measure>
    <time_frame>30-day, 1-year, and 2-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of 30-day, 1-year, and 2-year cardiac events</measure>
    <time_frame>30-day, 1-year, and 2-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of 30-day, 1-year, and 2-year myocardial infarction</measure>
    <time_frame>30-day, 1-year, and 2-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of 30-day, 1-year, and 2-year target vessel myocardial infarction</measure>
    <time_frame>30-day, 1-year, and 2-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of 30-day, 1-year, and 2-year revascularization</measure>
    <time_frame>30-day, 1-year, and 2-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of 30-day, 1-year, and 2-year target revascularization</measure>
    <time_frame>30-day, 1-year, and 2-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of 30-day, 1-year, and 2-year stroke</measure>
    <time_frame>30-day, 1-year, and 2-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of acute stent thrombosis at 24 hours, subacute stent thrombosis at 30 days, and stent thrombosis at 1 and 2 years</measure>
    <time_frame>24 hours, 30 days, 1 and 2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>BioMimeTM Stent</arm_group_label>
    <description>No intervention / Ischemic heart disease with percutaneous coronary intervention with BioMimeTM Stent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultimaster® Stent</arm_group_label>
    <description>No intervention / Ischemic heart disease with percutaneous coronary intervention with Ultimaster® stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BioMimeTM Stent, Ultimaster® Stent</intervention_name>
    <arm_group_label>BioMimeTM Stent</arm_group_label>
    <arm_group_label>Ultimaster® Stent</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Ischemic heart disease with percutaneous coronary intervention with stenting&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 19 years old or older&#xD;
&#xD;
          2. Clinical evidence of coronary artery disease including asymptomatic ischemia, stable&#xD;
             angina pectoris, acute coronary syndrome (unstable angina, non-ST segment elevation&#xD;
             myocardial infarction, ST segment elevation myocardial infarction).&#xD;
&#xD;
          3. Vessel diameter 2.25 ~ 3.5mm, stenosis more than 50% (However, the number of blood&#xD;
             vessels, the number of lesions, and the lesion length are not limited)&#xD;
&#xD;
          4. Voluntary written consent to participate in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Within 24 hours before percutaneous coronary intervention, hemodynamic instability or&#xD;
             cardiogenic shock&#xD;
&#xD;
          2. Life expectancy within 2 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyeon Cheol Gwon</last_name>
    <role>Study Chair</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hyeon Cheol Gwon</last_name>
    <email>hc.gwon@samsung.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Taek Kyu Park</last_name>
    <email>taekkyu.park@samsung.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hyoen-Cheol Gwon, PhD</last_name>
      <phone>82-2-3410-3418</phone>
      <email>hc.gwon@samsung.com</email>
    </contact>
    <investigator>
      <last_name>Hyoen-Cheol Gwon, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.</citation>
    <PMID>18430909</PMID>
  </reference>
  <reference>
    <citation>Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL. Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med. 2006 Dec;119(12):1056-61. doi: 10.1016/j.amjmed.2006.01.023.</citation>
    <PMID>17145250</PMID>
  </reference>
  <reference>
    <citation>Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.</citation>
    <PMID>17869634</PMID>
  </reference>
  <reference>
    <citation>Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vazquez N, Valdes M, Voudris V, Puricel S, Slagboom T, Goy JJ, den Heijer P, van der Ent M. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial. EuroIntervention. 2015 Jul;11(3):272-9. doi: 10.4244/EIJV11I3A53.</citation>
    <PMID>26196753</PMID>
  </reference>
  <reference>
    <citation>Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T. Final 3-Year Outcome of a Randomized Trial Comparing Second-Generation Drug-Eluting Stents Using Either Biodegradable Polymer or Durable Polymer: NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial. Circ Cardiovasc Interv. 2015 Oct;8(10):e002817. doi: 10.1161/CIRCINTERVENTIONS.115.002817.</citation>
    <PMID>26446596</PMID>
  </reference>
  <reference>
    <citation>Kang SH, Park KW, Kang DY, Lim WH, Park KT, Han JK, Kang HJ, Koo BK, Oh BH, Park YB, Kandzari DE, Cohen DJ, Hwang SS, Kim HS. Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis. Eur Heart J. 2014 May;35(17):1147-58. doi: 10.1093/eurheartj/eht570. Epub 2014 Jan 23.</citation>
    <PMID>24459196</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>February 7, 2018</last_update_submitted>
  <last_update_submitted_qc>February 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Hyeon-Cheol Gwon</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>BioMime, Ultimaster, Ischemic heart disease, DES</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02986295
org study id: 2016-04-059
nct id: NCT02986295
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with
      Xience® stent
A prospective, open, multicenter, and observational study will register and compare Xience®
      groups treated in institutions such as the BioMime ™, Ultimaster® group prospectively
      registered from June 2016.

      The Xience® group has already been registered in the previous study (SMARTDESK-BX), so
      BioMimeTM and Ultimaster® only need to be registered. Follow-up will be conducted until
      December 2019, and e-CRF will be completed by April 2020.
observational model: Cohort
time perspective: Prospective
measure: The incidence of 1-year target lesion failure
time frame: 1-year
description: The incidence of 1-year target lesion failure (combination of cardiac death, target vessel myocardial infarction, and target vessel revascularization).
measure: Incidence of 30-day and 2-year target lesion failure
time frame: 30-day and 2-year
measure: Incidence of 30-day, 1-year, and 2-year deaths
time frame: 30-day, 1-year, and 2-year
measure: Incidence of 30-day, 1-year, and 2-year cardiac events
time frame: 30-day, 1-year, and 2-year
measure: Incidence of 30-day, 1-year, and 2-year myocardial infarction
time frame: 30-day, 1-year, and 2-year
measure: Incidence of 30-day, 1-year, and 2-year target vessel myocardial infarction
time frame: 30-day, 1-year, and 2-year
measure: Incidence of 30-day, 1-year, and 2-year revascularization
time frame: 30-day, 1-year, and 2-year
measure: Incidence of 30-day, 1-year, and 2-year target revascularization
time frame: 30-day, 1-year, and 2-year
measure: Incidence of 30-day, 1-year, and 2-year stroke
time frame: 30-day, 1-year, and 2-year
measure: Incidence of acute stent thrombosis at 24 hours, subacute stent thrombosis at 30 days, and stent thrombosis at 1 and 2 years
time frame: 24 hours, 30 days, 1 and 2 years
arm group label: BioMimeTM Stent
description: No intervention / Ischemic heart disease with percutaneous coronary intervention with BioMimeTM Stent
arm group label: Ultimaster® Stent
description: No intervention / Ischemic heart disease with percutaneous coronary intervention with Ultimaster® stent
intervention type: Device
intervention name: BioMimeTM Stent, Ultimaster® Stent
arm group label: BioMimeTM Stent
arm group label: Ultimaster® Stent
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Hyeon Cheol Gwon
role: Study Chair
affiliation: Samsung Medical Center
last name: Hyeon Cheol Gwon
email: hc.gwon@samsung.com
last name: Taek Kyu Park
email: taekkyu.park@samsung.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
citation: Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.
PMID: 18430909
citation: Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL. Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med. 2006 Dec;119(12):1056-61. doi: 10.1016/j.amjmed.2006.01.023.
PMID: 17145250
citation: Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.
PMID: 17869634
citation: Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vazquez N, Valdes M, Voudris V, Puricel S, Slagboom T, Goy JJ, den Heijer P, van der Ent M. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial. EuroIntervention. 2015 Jul;11(3):272-9. doi: 10.4244/EIJV11I3A53.
PMID: 26196753
citation: Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T. Final 3-Year Outcome of a Randomized Trial Comparing Second-Generation Drug-Eluting Stents Using Either Biodegradable Polymer or Durable Polymer: NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial. Circ Cardiovasc Interv. 2015 Oct;8(10):e002817. doi: 10.1161/CIRCINTERVENTIONS.115.002817.
PMID: 26446596
citation: Kang SH, Park KW, Kang DY, Lim WH, Park KT, Han JK, Kang HJ, Koo BK, Oh BH, Park YB, Kandzari DE, Cohen DJ, Hwang SS, Kim HS. Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis. Eur Heart J. 2014 May;35(17):1147-58. doi: 10.1093/eurheartj/eht570. Epub 2014 Jan 23.
PMID: 24459196
responsible party type: Sponsor-Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Hyeon-Cheol Gwon
investigator title: Professor
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
sharing ipd: No