<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/NCT02183454</url>
  </required_header>
  <id_info>
    <org_study_id>VP-0639</org_study_id>
    <nct_id>NCT02183454</nct_id>
  </id_info>
  <brief_title>MASCOT - Post Marketing Registry</brief_title>
  <acronym>MASCOT</acronym>
  <official_title>Multinational Abluminal Sirolimus Coated BiO-Engineered StenT - The MASCOT Post Marketing Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OrbusNeich</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>OrbusNeich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To collect post marketing surveillance data on patients receiving at least one Combo&#xD;
      Bio-Engineered Sirolimus Eluting Stent when used according to the Instructions for Use. Data&#xD;
      will be collected in order to assess the long term safety and performance of the Combo Stent&#xD;
      in routine clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The multicenter, multinational, prospective registry population consists of patients who&#xD;
      undergo percutaneous coronary intervention (PCI) with (attempted) placement of at least one&#xD;
      Combo Stent (according to the Instructions for use) as part of routine clinical care.&#xD;
      Approximately 2,500 patients from 50 centers in Europe and Asia will be entered into the&#xD;
      registry. Patients entered into the registry are followed for one year. The registry is&#xD;
      considered finished when all patients have completed the 12 month follow-up.&#xD;
&#xD;
      A follow-up is scheduled at 30 days, 6 months and 12 months post procedure. Follow-up is&#xD;
      obtained at a planned regular visit to the outpatient clinic, or by telephone contact with&#xD;
      the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</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>Adjudicated device-oriented composite target lesion failure (TLF)</measure>
    <time_frame>12 months post procedure</time_frame>
    <description>Adjudicated device-oriented composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting (CABG)) at 12 months post procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adjudicated TLF</measure>
    <time_frame>at index procedure, 30 days, 6 months and 12 months post procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Each of the components of TLF (Cardiac death, Non-fatal MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR))</measure>
    <time_frame>at index procedure, 30 days, 6 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) as a composite of all Death, any MI and ischemia-driven revascularization (TLR/TVR/non-TVR)</measure>
    <time_frame>at index procedure, 30 days, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Each of the components of MACE (All death, Any myocardial infarction, Ischemia-driven revascularization)</measure>
    <time_frame>at index procedure, 30 days, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition</measure>
    <time_frame>at index procedure, 30 days, 6 months and 12 months post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjudicated bleeding per the Bleeding Academic Research Consortium (BARC) definition</measure>
    <time_frame>at index procedure, 30 days, 6 months and 12 months post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjudicated stroke</measure>
    <time_frame>at index procedure, 30 days, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success: Percentage of patients with a successful delivery and deployment of the Combo Stent to the target lesion and a final diameter stenosis after stenting ≤20% by visual assessment in the presence of grade 3 TIMI flow, by visual estimation</measure>
    <time_frame>Index Procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure success: Successful stent placement and no peri-procedural complications.</measure>
    <time_frame>Index procedure</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">2500</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Atherosclerosis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OrbusNeich COMBO stent</intervention_name>
    <description>The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients who undergo PCI with (attempted) placement of at least one Combo Stent&#xD;
        as part of routine clinical care are entered into the registry. PCI with a Combo Stent is&#xD;
        considered attempted when the operator has passed the Combo Stent across the guiding&#xD;
        catheter.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        In general, consecutive patients are included in the registry. Patients are only excluded&#xD;
        from registration if ANY of the following conditions apply:&#xD;
&#xD;
          1. Undergoing PCI for treatment of stent thrombosis&#xD;
&#xD;
          2. High probability of non-adherence to the follow-up requirements (due to social,&#xD;
             psychological or medical reasons)&#xD;
&#xD;
          3. Currently participating in another investigational drug or device study in which a&#xD;
             routine angiographic follow-up is planned&#xD;
&#xD;
          4. A life expectancy of &lt;12 months&#xD;
&#xD;
          5. Explicit refusal of participation in the registry&#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>Antonio Colombo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Raffaele Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amphia Ziekenhuis</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>June 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intracoronary stent</keyword>
  <keyword>drug eluting stent</keyword>
  <keyword>sirolimus</keyword>
  <keyword>endothelial progenitor cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Atherosclerosis</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/NCT02183454
org study id: VP-0639
nct id: NCT02183454
lead sponsor: 
collaborator: 
has dmc: Yes
To collect post marketing surveillance data on patients receiving at least one Combo
      Bio-Engineered Sirolimus Eluting Stent when used according to the Instructions for Use. Data
      will be collected in order to assess the long term safety and performance of the Combo Stent
      in routine clinical practice.
The multicenter, multinational, prospective registry population consists of patients who
      undergo percutaneous coronary intervention (PCI) with (attempted) placement of at least one
      Combo Stent (according to the Instructions for use) as part of routine clinical care.
      Approximately 2,500 patients from 50 centers in Europe and Asia will be entered into the
      registry. Patients entered into the registry are followed for one year. The registry is
      considered finished when all patients have completed the 12 month follow-up.

      A follow-up is scheduled at 30 days, 6 months and 12 months post procedure. Follow-up is
      obtained at a planned regular visit to the outpatient clinic, or by telephone contact with
      the patient.
observational model: Cohort
time perspective: Prospective
measure: Adjudicated device-oriented composite target lesion failure (TLF)
time frame: 12 months post procedure
description: Adjudicated device-oriented composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting (CABG)) at 12 months post procedure.
measure: Adjudicated TLF
time frame: at index procedure, 30 days, 6 months and 12 months post procedure
measure: Each of the components of TLF (Cardiac death, Non-fatal MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR))
time frame: at index procedure, 30 days, 6 months, 12 months
measure: Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) as a composite of all Death, any MI and ischemia-driven revascularization (TLR/TVR/non-TVR)
time frame: at index procedure, 30 days, 6 months and 12 months
measure: Each of the components of MACE (All death, Any myocardial infarction, Ischemia-driven revascularization)
time frame: at index procedure, 30 days, 6 months and 12 months
measure: Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition
time frame: at index procedure, 30 days, 6 months and 12 months post-procedure
measure: Adjudicated bleeding per the Bleeding Academic Research Consortium (BARC) definition
time frame: at index procedure, 30 days, 6 months and 12 months post-procedure
measure: Adjudicated stroke
time frame: at index procedure, 30 days, 6 months and 12 months
measure: Device success: Percentage of patients with a successful delivery and deployment of the Combo Stent to the target lesion and a final diameter stenosis after stenting ≤20% by visual assessment in the presence of grade 3 TIMI flow, by visual estimation
time frame: Index Procedure
measure: Procedure success: Successful stent placement and no peri-procedural complications.
time frame: Index procedure
intervention type: Device
intervention name: OrbusNeich COMBO stent
description: The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antonio Colombo, MD
role: Principal Investigator
affiliation: San Raffaele Hospital
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Atherosclerosis