<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/NCT04500912</url>
  </required_header>
  <id_info>
    <org_study_id>NL73419.100.20</org_study_id>
    <nct_id>NCT04500912</nct_id>
  </id_info>
  <brief_title>Comparison of the Supraflex Cruz 60 Micron Versus the Ultimaster Tansei 80 Micron in HBR PCI Population</brief_title>
  <official_title>Comparison of the Supraflex Cruz 60 Micron Stent Strut Versus the Ultimaster Tansei 80 Micron Stent Strut in High Bleeding Risk PCI Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pieter C.Smits</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sahajanand Medical Technologies Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Research Maatschap Cardiologen Rotterdam Zuid</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study compares the outcome of the ultrathin stent strut Supraflex Cruz stent to the thin&#xD;
      stent strut Ultimaster Tansei stent in a PCI population at high risk for bleeding (HBR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: An Investigator-initiated, multi-center, randomized clinical trial in HBR&#xD;
      patients receiving PCI with Supraflex Cruz or Ultimaster Tansei stents&#xD;
&#xD;
      Study population: 2 x 368 (736) patients, who undergo a PCI and are at high risk for bleeding&#xD;
      (HBR).&#xD;
&#xD;
      Intervention: Patients are treated according to the randomized regimen at index PCI and at&#xD;
      planned staged procedures. Either with the ultrathin stent strut Supraflex Cruz stent to the&#xD;
      thin stent strut Ultimaster Tansei stent&#xD;
&#xD;
      DAPT treatment (combination and duration) is according to the Guidelines of the European&#xD;
      Society of Cardiology for Myocardial Revascularization.&#xD;
&#xD;
      Follow-up is scheduled at 1 month, 6 months and 12 months post index PCI procedure.&#xD;
&#xD;
      Primary study parameters/outcome of the study:&#xD;
&#xD;
      The primary endpoint Net Adverse Clinical Endpoints (NACE) defined as a composite of&#xD;
      cardiovascular death, myocardial infarction, target vessel revascularization, stroke and&#xD;
      bleeding events defined as BARC 3 or 5 at 12 months follow-up after the index PCI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Actual">September 1, 2023</completion_date>
  <primary_completion_date type="Actual">September 1, 2023</primary_completion_date>
  <phase>N/A</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>Single (Participant)</masking>
    <masking_description>Patient will be blinded for the stent that is used</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Net Adverse Clinical Endpoints (NACE)</measure>
    <time_frame>1 year</time_frame>
    <description>The primary endpoint Net Adverse Clinical Endpoints (NACE) defined as a composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke and bleeding events defined as BARC 3 or 5 at 12 months follow-up after the index PCI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac and cerebral events (MACCE)</measure>
    <time_frame>1 year</time_frame>
    <description>Major adverse cardiac and cerebral events (MACCE) defined as a composite of cardiac death, myocardial infarction, target vessel revascularization and stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major or clinically relevant non-major bleeding (MCB)</measure>
    <time_frame>1 year</time_frame>
    <description>Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Failure (TLF)</measure>
    <time_frame>1 year</time_frame>
    <description>Target Lesion Failure (TLF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel failure (TVF)</measure>
    <time_frame>1 year</time_frame>
    <description>Target Vessel Failure (TVF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target vessel revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The composite of cardiovascular death, myocardial infarction and stroke</measure>
    <time_frame>1 year</time_frame>
    <description>The composite endpoint of cardiovascular death, myocardial infarction and stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The composite of cardiovascular death, myocardial infarction, stroke and major bleed BARC 3 and 5</measure>
    <time_frame>1 year</time_frame>
    <description>The composite of cardiovascular death, myocardial infarction, stroke and major bleed according to BARC 3 and 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>1 year</time_frame>
    <description>Stent thrombosis according to the ARC definitions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>1 year</time_frame>
    <description>Myocardial infarction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urgent target vessel revascularization</measure>
    <time_frame>1 year</time_frame>
    <description>Urgent target vessel revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-target vessel revascularization</measure>
    <time_frame>1 year</time_frame>
    <description>Non-target vessel revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically indicated target vessel revascularization</measure>
    <time_frame>1 year</time_frame>
    <description>Clinically indicated target vessel revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding events</measure>
    <time_frame>1 year</time_frame>
    <description>Bleeding events according to the BARC, TIMI and GUSTO classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusion rates</measure>
    <time_frame>1 year</time_frame>
    <description>Transfusion rates both in patients with and/or without clinically detected over bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rates according to the PRECISE-DAPT</measure>
    <time_frame>1 year</time_frame>
    <description>Event rates according to the PRECISE-DAPT score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural success</measure>
    <time_frame>At completion of the baseline PCI</time_frame>
    <description>Procedural success is defined as angiographic success with no in-hospital MACE, defined as death, MI with new Q-waves on electrocardiogram (ECG) or urgent target vessel revascularization (TVR) (including both repeat PCI and coronary artery bypass graft surgery (CABG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>At discharge of baseline hospitalisation, on average 3 days</time_frame>
    <description>Device success (applying a lesion-level analysis)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">736</enrollment>
  <condition>Cardiac Disease</condition>
  <condition>PCI</condition>
  <condition>High Bleeding Risk</condition>
  <arm_group>
    <arm_group_label>Supraflex Cruz stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Randomization to Supraflex Cruz stent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultimaster Tansei stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Randomization to Ultimaster Tansei stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Supraflex Cruz 60 Micron</intervention_name>
    <description>percutaneous coronary intervention</description>
    <arm_group_label>Supraflex Cruz stent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultimaster Tansei 80 Micron</intervention_name>
    <description>percutaneous coronary intervention</description>
    <arm_group_label>Ultimaster Tansei stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Patients are eligible for inclusion into the study if the following criteria are met.&#xD;
&#xD;
          -  Patients of 18 years and above&#xD;
&#xD;
          -  Written or witnessed oral consent to participate in the study&#xD;
&#xD;
          -  Native coronary artery lesions eligible for PCI with stents with no restrictions in&#xD;
             number of lesions and stents, vessel size or lesion complexity, apart from stent&#xD;
             thrombosis.&#xD;
&#xD;
          -  Patients at high risk for bleeding according to the HBR ARC criteria: Patients meet&#xD;
             the HBR ARC criteria if ≥1 major or ≥2 minor criteria are met.&#xD;
&#xD;
        Major HBR criteria are the following:&#xD;
&#xD;
          -  Clinical indication for treatment with oral anticoagulants (OAC/NOAC) for at least 12&#xD;
             months&#xD;
&#xD;
          -  Severe or end-stage chronic kidney failure (GFR ≤ 30 ml/min)&#xD;
&#xD;
          -  Hemoglobin (Hb) level at screening &lt; 11g/dl or &lt; 6.8 mmol/l&#xD;
&#xD;
          -  Spontaneous bleeding requiring hospitalization or transfusion in the past 6 months or&#xD;
             at any time, if recurrent&#xD;
&#xD;
          -  Moderate or severe baseline true thrombocytopenia (platelet count &lt;100 *10^9/L)&#xD;
&#xD;
          -  History of chronic bleeding diathesis, like: leukemia, haemophilia, vitamin K&#xD;
             deficiency, Factor V or VII deficiency etc.&#xD;
&#xD;
          -  Liver cirrhosis with portal hypertension&#xD;
&#xD;
          -  Active malignancy (other than skin) within the past 12 months&#xD;
&#xD;
          -  Spontaneous intracranial haemorrhage ICH (at any time)&#xD;
&#xD;
          -  Traumatic intracranial haemorrhage ICH within 12 months&#xD;
&#xD;
          -  Presence of a brain arterio-venous malformation (AVM)&#xD;
&#xD;
          -  Moderate or severe ischemic stroke within the past 6 months&#xD;
&#xD;
          -  Nondeferrable major surgery on DAPT after PCI&#xD;
&#xD;
          -  Recent major surgery or major trauma within 30 d before PCI&#xD;
&#xD;
        Minor HBR criteria are the following:&#xD;
&#xD;
          -  Age ≥ 75 years&#xD;
&#xD;
          -  Moderate chronic kidney disease (GFR &gt;30 and &lt;60 ml/min)&#xD;
&#xD;
          -  Hemoglobin (Hb) 11-12.9 g/dL / 6.8-8.0 mmol/l for men and 11-11.9 g/dL / 6.8-7.4&#xD;
             mmol/l for women&#xD;
&#xD;
          -  Any ischemic stroke at any time not meeting the major criterion&#xD;
&#xD;
          -  Spontaneous bleeding requiring hospitalization or transfusion within the past 12&#xD;
             months&#xD;
&#xD;
          -  Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Patients are not eligible if any of the following applies:&#xD;
&#xD;
          -  Treated with stents other than Supraflex Cruz or Ultimaster within 6 months prior to&#xD;
             index procedure&#xD;
&#xD;
          -  Treatment of lesions with stent thrombosis&#xD;
&#xD;
          -  Treatment of venous or arterial coronary grafts&#xD;
&#xD;
          -  Treated for stent thrombosis in 12 months prior to index PCI procedure&#xD;
&#xD;
          -  Treated with a bioresorbable scaffold 3 years before index PCI procedure&#xD;
&#xD;
          -  Cardiogenic shock at index procedure&#xD;
&#xD;
          -  Active SARS-CoV-2 infection or suspicion of SARS-CoV-2 infection&#xD;
&#xD;
          -  Cannot provide written informed consent&#xD;
&#xD;
          -  Under judicial protection, tutorship or curatorship&#xD;
&#xD;
          -  Unable to understand and follow study-related instructions or unable to comply with&#xD;
             study protocol&#xD;
&#xD;
          -  Active bleeding requiring medical attention (BARC≥2) at index PCI&#xD;
&#xD;
          -  Life expectancy less than one year&#xD;
&#xD;
          -  Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel,&#xD;
             cobalt chromium or sirolimus&#xD;
&#xD;
          -  Any anticipated PCI after index PCI, unless planned and scheduled at index PCI&#xD;
&#xD;
          -  Participation in another stent or drug trial&#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>Pieter Smits, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Maatschap Cardiologen Rotterdam Zuid</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jeroen Bosch ziekenhuis</name>
      <address>
        <city>'s-Hertogenbosch</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meander ziekenhuis</name>
      <address>
        <city>Amersfoort</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rijnstate ziekenhuis</name>
      <address>
        <city>Arnhem</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tergooi ziekenhuis Blaricum</name>
      <address>
        <city>Blaricum</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia Ziekenhuis</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Schweitzer ziekenhuis</name>
      <address>
        <city>Dordrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catherina ziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MCL Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Antonius ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maasstadziekenhuis</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Zorgsaam</name>
      <address>
        <city>Terneuzen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Research Maatschap Cardiologen Rotterdam Zuid</investigator_affiliation>
    <investigator_full_name>Pieter C.Smits</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Hemorrhage</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/NCT04500912
org study id: NL73419.100.20
nct id: NCT04500912
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study compares the outcome of the ultrathin stent strut Supraflex Cruz stent to the thin
      stent strut Ultimaster Tansei stent in a PCI population at high risk for bleeding (HBR).
Study design: An Investigator-initiated, multi-center, randomized clinical trial in HBR
      patients receiving PCI with Supraflex Cruz or Ultimaster Tansei stents

      Study population: 2 x 368 (736) patients, who undergo a PCI and are at high risk for bleeding
      (HBR).

      Intervention: Patients are treated according to the randomized regimen at index PCI and at
      planned staged procedures. Either with the ultrathin stent strut Supraflex Cruz stent to the
      thin stent strut Ultimaster Tansei stent

      DAPT treatment (combination and duration) is according to the Guidelines of the European
      Society of Cardiology for Myocardial Revascularization.

      Follow-up is scheduled at 1 month, 6 months and 12 months post index PCI procedure.

      Primary study parameters/outcome of the study:

      The primary endpoint Net Adverse Clinical Endpoints (NACE) defined as a composite of
      cardiovascular death, myocardial infarction, target vessel revascularization, stroke and
      bleeding events defined as BARC 3 or 5 at 12 months follow-up after the index PCI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Patient will be blinded for the stent that is used
measure: Net Adverse Clinical Endpoints (NACE)
time frame: 1 year
description: The primary endpoint Net Adverse Clinical Endpoints (NACE) defined as a composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke and bleeding events defined as BARC 3 or 5 at 12 months follow-up after the index PCI.
measure: Major adverse cardiac and cerebral events (MACCE)
time frame: 1 year
description: Major adverse cardiac and cerebral events (MACCE) defined as a composite of cardiac death, myocardial infarction, target vessel revascularization and stroke
measure: Major or clinically relevant non-major bleeding (MCB)
time frame: 1 year
description: Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events
measure: Target Lesion Failure (TLF)
time frame: 1 year
description: Target Lesion Failure (TLF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target lesion revascularization
measure: Target vessel failure (TVF)
time frame: 1 year
description: Target Vessel Failure (TVF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target vessel revascularization
measure: The composite of cardiovascular death, myocardial infarction and stroke
time frame: 1 year
description: The composite endpoint of cardiovascular death, myocardial infarction and stroke
measure: The composite of cardiovascular death, myocardial infarction, stroke and major bleed BARC 3 and 5
time frame: 1 year
description: The composite of cardiovascular death, myocardial infarction, stroke and major bleed according to BARC 3 and 5
measure: Stent thrombosis
time frame: 1 year
description: Stent thrombosis according to the ARC definitions
measure: Myocardial infarction
time frame: 1 year
description: Myocardial infarction.
measure: Urgent target vessel revascularization
time frame: 1 year
description: Urgent target vessel revascularization.
measure: Non-target vessel revascularization
time frame: 1 year
description: Non-target vessel revascularization.
measure: Clinically indicated target vessel revascularization
time frame: 1 year
description: Clinically indicated target vessel revascularization.
measure: Bleeding events
time frame: 1 year
description: Bleeding events according to the BARC, TIMI and GUSTO classification
measure: Transfusion rates
time frame: 1 year
description: Transfusion rates both in patients with and/or without clinically detected over bleeding
measure: Event rates according to the PRECISE-DAPT
time frame: 1 year
description: Event rates according to the PRECISE-DAPT score
measure: Procedural success
time frame: At completion of the baseline PCI
description: Procedural success is defined as angiographic success with no in-hospital MACE, defined as death, MI with new Q-waves on electrocardiogram (ECG) or urgent target vessel revascularization (TVR) (including both repeat PCI and coronary artery bypass graft surgery (CABG)
measure: Device success
time frame: At discharge of baseline hospitalisation, on average 3 days
description: Device success (applying a lesion-level analysis)
arm group label: Supraflex Cruz stent
arm group type: Active Comparator
description: Randomization to Supraflex Cruz stent
arm group label: Ultimaster Tansei stent
arm group type: Active Comparator
description: Randomization to Ultimaster Tansei stent
intervention type: Device
intervention name: Supraflex Cruz 60 Micron
description: percutaneous coronary intervention
arm group label: Supraflex Cruz stent
intervention type: Device
intervention name: Ultimaster Tansei 80 Micron
description: percutaneous coronary intervention
arm group label: Ultimaster Tansei stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pieter Smits, MD, PhD
role: Principal Investigator
affiliation: Research Maatschap Cardiologen Rotterdam Zuid
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Sponsor-Investigator
investigator affiliation: Research Maatschap Cardiologen Rotterdam Zuid
investigator full name: Pieter C.Smits
investigator title: MD, PhD
mesh term: Heart Diseases
mesh term: Hemorrhage