<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/NCT04475536</url>
  </required_header>
  <id_info>
    <org_study_id>EPIC08-TANSEI</org_study_id>
    <nct_id>NCT04475536</nct_id>
  </id_info>
  <brief_title>A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.</brief_title>
  <acronym>TANSEI</acronym>
  <official_title>A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación EPIC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación EPIC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective registry is intended to evaluate the safety and efficacy of the TANSEI&#xD;
      stent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective registry is intended to analyze clinical outcomes in patients treated with&#xD;
      TANSEI stent in patients with complex coronary lesions .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 21, 2020</start_date>
  <completion_date type="Anticipated">February 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2023</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>12 Months</target_duration>
  <primary_outcome>
    <measure>Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).</measure>
    <time_frame>12 months</time_frame>
    <description>The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy.The incidence of clinically driven target lesion revascularization.</measure>
    <time_frame>12 months</time_frame>
    <description>The incidence of clinically driven target lesion revascularization (TLR).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All death.</measure>
    <time_frame>12 months</time_frame>
    <description>All death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death.</measure>
    <time_frame>12 months</time_frame>
    <description>Cardiac death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Vessel revascularization.</measure>
    <time_frame>12 months</time_frame>
    <description>Target Vessel revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion revascularization.</measure>
    <time_frame>12 months</time_frame>
    <description>Target lesion revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis (ARC definite/probable).</measure>
    <time_frame>12 months</time_frame>
    <description>Stent thrombosis (ARC definite/probable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major bleeding event (BARC type 2-5).</measure>
    <time_frame>12 months</time_frame>
    <description>Major bleeding event (BARC type 2-5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke.</measure>
    <time_frame>12 months</time_frame>
    <description>Stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural success.</measure>
    <time_frame>12 months</time_frame>
    <description>Procedural success ( Residual stenosis &lt;30% after implantation at the narrowest point of the treated vascular segment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with DAPT</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>Rate of patients with DAPT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with DAPT</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>Rate of patients with DAPT</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">501</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Coronary Artery Disease (CAD)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TANSEI stent</intervention_name>
    <description>stenting with the TANSEI sirolimus-eluting stent</description>
    <arm_group_label>Coronary Artery Disease (CAD)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with de novo native and complex coronary artery lesions, candidate to undergo&#xD;
        revascularisation with a coronary device.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 18 years.&#xD;
&#xD;
          -  With indication of percutaneous revascularization.&#xD;
&#xD;
          -  Complex coronary lesion defined as:&#xD;
&#xD;
               -  Left main lesion AND/OR&#xD;
&#xD;
               -  Lesion located at a major bifurcation (side branch &gt;2mm) AND/OR&#xD;
&#xD;
               -  Lesion located in a small vessel (&lt;2.5 mm reference diameter by visual&#xD;
                  estimation) AND/OR&#xD;
&#xD;
               -  Lesion length &gt; 35 mm&#xD;
&#xD;
          -  Informed consent signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiogenic shock at the time of the PCI(Percutaneous Coronary Intervention).&#xD;
&#xD;
          -  Life expectancy of the patient under 1 year.&#xD;
&#xD;
          -  Patients included in other studies or clinical trials.&#xD;
&#xD;
          -  Clinical decision that excludes the use of drug-eluting stents.&#xD;
&#xD;
          -  Confirmed allergy to aspirin and / or thienopyridines.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Santiago de Compostela</name>
      <address>
        <city>Santiago De Compostela</city>
        <state>LA Coruña</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario</name>
      <address>
        <city>Albacete</city>
        <zip>02006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall D'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Ciudad Real</name>
      <address>
        <city>Ciudad Real</city>
        <zip>13005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de A Coruña</name>
      <address>
        <city>Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Cabueñes</name>
      <address>
        <city>Gijón</city>
        <zip>33394</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Juan Ramon Jimenez</name>
      <address>
        <city>Huelva</city>
        <zip>21005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Gran Canaria Dr. Negrin</name>
      <address>
        <city>Las Palmas De Gran Canaria</city>
        <zip>35010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de León</name>
      <address>
        <city>León</city>
        <zip>24001</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Lucus Agusti</name>
      <address>
        <city>Lugo</city>
        <zip>27003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro</name>
      <address>
        <city>Majadahonda</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Virgen Arrixaca</name>
      <address>
        <city>Murcia</city>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de La Victoria</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marques de Valdcilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Saito S, Valdes-Chavarri M, Richardt G, Moreno R, Iniguez Romo A, Barbato E, Carrie D, Ando K, Merkely B, Kornowski R, Eltchaninoff H, James S, Wijns W; CENTURY II Investigators. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial. Eur Heart J. 2014 Aug 7;35(30):2021-31. doi: 10.1093/eurheartj/ehu210. Epub 2014 May 19.</citation>
    <PMID>24847155</PMID>
  </reference>
  <reference>
    <citation>Orvin K, Carrie D, Richardt G, Desmet W, Assali A, Werner G, Ikari Y, Fujii K, Goicolea J, Dangoisse V, Manari A, Saito S, Wijns W, Kornowski R. Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial. Catheter Cardiovasc Interv. 2016 May;87(6):1092-100. doi: 10.1002/ccd.26150. Epub 2015 Aug 13.</citation>
    <PMID>26268482</PMID>
  </reference>
  <reference>
    <citation>Lesiak M, Araszkiewicz A, Grajek S, Colombo A, Lalmand J, Carstensen S, Namiki A, Tobaru T, Merkely B, Moreno R, Barbato E, Wijns W, Saito S. Long Coronary Lesions Treated With Thin Strut Bioresorbable Polymer Drug Eluting Stent: Experience From Multicentre Randomized CENTURY II Study. J Interv Cardiol. 2016 Feb;29(1):47-56. doi: 10.1111/joic.12262.</citation>
    <PMID>26864951</PMID>
  </reference>
  <reference>
    <citation>Derimay F, Souteyrand G, Motreff P, Rioufol G, Finet G. Influence of platform design of six different drug-eluting stents in provisional coronary bifurcation stenting by rePOT sequence: a comparative bench analysis. EuroIntervention. 2017 Oct 13;13(9):e1092-e1095. doi: 10.4244/EIJ-D-16-00863.</citation>
    <PMID>28485275</PMID>
  </reference>
  <reference>
    <citation>Chevalier B, Smits PC, Carrie D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamie D, Kraaijeveld AO, Hovasse T, Vlachojannis GJ. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months). Circ Cardiovasc Interv. 2017 Dec;10(12):e004801. doi: 10.1161/CIRCINTERVENTIONS.116.004801.</citation>
    <PMID>29246909</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Complex Lesions</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>Heart Diseases</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/NCT04475536
org study id: EPIC08-TANSEI
nct id: NCT04475536
lead sponsor: 
has dmc: Yes
This prospective registry is intended to evaluate the safety and efficacy of the TANSEI
      stent.
This prospective registry is intended to analyze clinical outcomes in patients treated with
      TANSEI stent in patients with complex coronary lesions .
observational model: Cohort
time perspective: Prospective
measure: Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
time frame: 12 months
description: The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
measure: Efficacy.The incidence of clinically driven target lesion revascularization.
time frame: 12 months
description: The incidence of clinically driven target lesion revascularization (TLR).
measure: All death.
time frame: 12 months
description: All death.
measure: Cardiac death.
time frame: 12 months
description: Cardiac death.
measure: Target Vessel revascularization.
time frame: 12 months
description: Target Vessel revascularization.
measure: Target lesion revascularization.
time frame: 12 months
description: Target lesion revascularization.
measure: Stent thrombosis (ARC definite/probable).
time frame: 12 months
description: Stent thrombosis (ARC definite/probable).
measure: Major bleeding event (BARC type 2-5).
time frame: 12 months
description: Major bleeding event (BARC type 2-5).
measure: Stroke.
time frame: 12 months
description: Stroke.
measure: Procedural success.
time frame: 12 months
description: Procedural success ( Residual stenosis <30% after implantation at the narrowest point of the treated vascular segment).
measure: Rate of patients with DAPT
time frame: From 1 to 6 months
description: Rate of patients with DAPT
measure: Rate of patients with DAPT
time frame: From 6 to 12 months
description: Rate of patients with DAPT
arm group label: Coronary Artery Disease (CAD)
intervention type: Device
intervention name: TANSEI stent
description: stenting with the TANSEI sirolimus-eluting stent
arm group label: Coronary Artery Disease (CAD)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
citation: Saito S, Valdes-Chavarri M, Richardt G, Moreno R, Iniguez Romo A, Barbato E, Carrie D, Ando K, Merkely B, Kornowski R, Eltchaninoff H, James S, Wijns W; CENTURY II Investigators. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial. Eur Heart J. 2014 Aug 7;35(30):2021-31. doi: 10.1093/eurheartj/ehu210. Epub 2014 May 19.
PMID: 24847155
citation: Orvin K, Carrie D, Richardt G, Desmet W, Assali A, Werner G, Ikari Y, Fujii K, Goicolea J, Dangoisse V, Manari A, Saito S, Wijns W, Kornowski R. Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial. Catheter Cardiovasc Interv. 2016 May;87(6):1092-100. doi: 10.1002/ccd.26150. Epub 2015 Aug 13.
PMID: 26268482
citation: Lesiak M, Araszkiewicz A, Grajek S, Colombo A, Lalmand J, Carstensen S, Namiki A, Tobaru T, Merkely B, Moreno R, Barbato E, Wijns W, Saito S. Long Coronary Lesions Treated With Thin Strut Bioresorbable Polymer Drug Eluting Stent: Experience From Multicentre Randomized CENTURY II Study. J Interv Cardiol. 2016 Feb;29(1):47-56. doi: 10.1111/joic.12262.
PMID: 26864951
citation: Derimay F, Souteyrand G, Motreff P, Rioufol G, Finet G. Influence of platform design of six different drug-eluting stents in provisional coronary bifurcation stenting by rePOT sequence: a comparative bench analysis. EuroIntervention. 2017 Oct 13;13(9):e1092-e1095. doi: 10.4244/EIJ-D-16-00863.
PMID: 28485275
citation: Chevalier B, Smits PC, Carrie D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamie D, Kraaijeveld AO, Hovasse T, Vlachojannis GJ. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months). Circ Cardiovasc Interv. 2017 Dec;10(12):e004801. doi: 10.1161/CIRCINTERVENTIONS.116.004801.
PMID: 29246909
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Heart Diseases