<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/NCT04465669</url>
  </required_header>
  <id_info>
    <org_study_id>Healing Stent</org_study_id>
    <nct_id>NCT04465669</nct_id>
  </id_info>
  <brief_title>Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation</brief_title>
  <acronym>Healing</acronym>
  <official_title>Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tomsk National Research Medical Center of the Russian Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tomsk National Research Medical Center of the Russian Academy of Sciences</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 objective of this study is a comparative evaluation of Orsiro stent and of Resolute&#xD;
      Integrity stent in terms of the extent of neointima formation at 4 months after implantation&#xD;
      using optical coherence tomography (OCT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      About 50 patients with clinical evidence of ischemic heart disease and / or a positive&#xD;
      functional study and documented stable angina pectoris (Canadian cardiovascular society&#xD;
      classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native,&#xD;
      previously unstented vessel in Tyumen Cardiology Center,will be randomly assigned undergoing&#xD;
      implantation of Orsiro stent or Resolute Integrity stent (in a 1:1 ratio).&#xD;
&#xD;
      All of the patients will receive 12 months dual antiplatelet therapy and they will be&#xD;
      followed (at the outpatient clinic) for up to 1 year. The follow-up visits will be conducted&#xD;
      at 4 months (including angiographic/OCT investigation), and 1 year post percutaneous coronary&#xD;
      intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2020</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>
    <intervention_model_description>About 50 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Tyumen Cardiology Center,will be randomly assigned undergoing implantation of Orsiro stent or Resolute Integrity stent (in a 1:1 ratio).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heterogeneous neointimal healing</measure>
    <time_frame>4 ± 1 months</time_frame>
    <description>Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Malapposed stent struts</measure>
    <time_frame>4 ± 1 months</time_frame>
    <description>Percentage of malapposed stent struts by optical coherence tomography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neointimal growth</measure>
    <time_frame>4 ± 1 months</time_frame>
    <description>Neointimal thickness by optical coherence tomography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic reference vessel diameter</measure>
    <time_frame>4 ± 1 months</time_frame>
    <description>Reference diameter of coronary artery by QCA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical composite endpoints</measure>
    <time_frame>12 months</time_frame>
    <description>Cardiac death/Target vessel MI/Clinically indicated TLR All death/All MI/All TVR (including TLR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Thrombosis</measure>
    <time_frame>12 months</time_frame>
    <description>Definite stent thrombosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncovered stent struts</measure>
    <time_frame>4 ± 1 months</time_frame>
    <description>Percentage of uncovered stent struts by optical coherence tomography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic minimal lumen diameter</measure>
    <time_frame>4 ± 1 months</time_frame>
    <description>Minimal lumen diameter of coronary artery by QCA;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic diameter stenosis</measure>
    <time_frame>4 ± 1 months</time_frame>
    <description>Percent diameter stenosis by QCA;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binary restenosis</measure>
    <time_frame>4 ± 1 months</time_frame>
    <description>Binary restenosis by QCA;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic late lumen loss</measure>
    <time_frame>4 ± 1 months</time_frame>
    <description>Late lumen loss by QCA;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Coronary Heart Disease</condition>
  <condition>Stable Angina Pectoris</condition>
  <condition>Silent Myocardial Ischemia</condition>
  <arm_group>
    <arm_group_label>Orsiro</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implantation of a Orsiro® biolimus a9 eluting coronary stent (drug-eluting stent, DES)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resolute Integrity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implantation of a Resolute Integrity® zotarolimus eluting coronary stent (drug-eluting stent, DES)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Orsiro stents</intervention_name>
    <description>Percutaneous coronary intervention with implantation of either:&#xD;
a Orsiro® biolimus a9 eluting coronary stent</description>
    <arm_group_label>Orsiro</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Resolute Integrity® stents</intervention_name>
    <description>Percutaneous coronary intervention with implantation of either:&#xD;
a Resolute Integrity® zotarolimus eluting coronary stent</description>
    <arm_group_label>Resolute Integrity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years;&#xD;
&#xD;
          -  Patients with symptoms of stable angina and/or presence of a positive functional test&#xD;
             for ischemia;&#xD;
&#xD;
          -  Patient is eligible for percutaneous coronary intervention (PCI);&#xD;
&#xD;
          -  Patient has been informed of the nature of the study and agrees to its provisions and&#xD;
             has provided written informed consent as approved by the Ethical Committee of the&#xD;
             respective clinical site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Target lesion involving a bifurcation with a side branch ≥2.0 mm in diameter;&#xD;
&#xD;
          -  Target lesion located in the left main stem;&#xD;
&#xD;
          -  Target lesion is located or supplied by an arterial or venous bypass graft;&#xD;
&#xD;
          -  Lesion located very distally, difficult to be imaged by OCT;&#xD;
&#xD;
          -  Co-morbidities that could interfere with completion of study procedures, or life&#xD;
             expectancy less than 1 year;&#xD;
&#xD;
          -  Participating in another investigational drug or device trial that has not completed&#xD;
             the primary endpoint or would interfere with the endpoints of this study;&#xD;
&#xD;
          -  Patient underwent target vessel revascularization with a DES;&#xD;
&#xD;
          -  Patient presenting with acute myocardial infarction with ST elevation;&#xD;
&#xD;
          -  Cerebrovascular accident within the past 12 months;&#xD;
&#xD;
          -  Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);&#xD;
&#xD;
          -  Patient receiving oral anticoagulants&#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>Bessonov S Ivan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tyumen Cardiology Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science</name>
      <address>
        <city>Tyumen</city>
        <zip>625026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT04465669/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04465669
org study id: Healing Stent
nct id: NCT04465669
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is a comparative evaluation of Orsiro stent and of Resolute
      Integrity stent in terms of the extent of neointima formation at 4 months after implantation
      using optical coherence tomography (OCT).
About 50 patients with clinical evidence of ischemic heart disease and / or a positive
      functional study and documented stable angina pectoris (Canadian cardiovascular society
      classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native,
      previously unstented vessel in Tyumen Cardiology Center,will be randomly assigned undergoing
      implantation of Orsiro stent or Resolute Integrity stent (in a 1:1 ratio).

      All of the patients will receive 12 months dual antiplatelet therapy and they will be
      followed (at the outpatient clinic) for up to 1 year. The follow-up visits will be conducted
      at 4 months (including angiographic/OCT investigation), and 1 year post percutaneous coronary
      intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: About 50 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Tyumen Cardiology Center,will be randomly assigned undergoing implantation of Orsiro stent or Resolute Integrity stent (in a 1:1 ratio).
primary purpose: Treatment
masking: Single (Participant)
measure: Heterogeneous neointimal healing
time frame: 4 ± 1 months
description: Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography
measure: Malapposed stent struts
time frame: 4 ± 1 months
description: Percentage of malapposed stent struts by optical coherence tomography
measure: Neointimal growth
time frame: 4 ± 1 months
description: Neointimal thickness by optical coherence tomography
measure: Angiographic reference vessel diameter
time frame: 4 ± 1 months
description: Reference diameter of coronary artery by QCA
measure: Clinical composite endpoints
time frame: 12 months
description: Cardiac death/Target vessel MI/Clinically indicated TLR All death/All MI/All TVR (including TLR)
measure: Stent Thrombosis
time frame: 12 months
description: Definite stent thrombosis
measure: Uncovered stent struts
time frame: 4 ± 1 months
description: Percentage of uncovered stent struts by optical coherence tomography
measure: Angiographic minimal lumen diameter
time frame: 4 ± 1 months
description: Minimal lumen diameter of coronary artery by QCA;
measure: Angiographic diameter stenosis
time frame: 4 ± 1 months
description: Percent diameter stenosis by QCA;
measure: Binary restenosis
time frame: 4 ± 1 months
description: Binary restenosis by QCA;
measure: Angiographic late lumen loss
time frame: 4 ± 1 months
description: Late lumen loss by QCA;
arm group label: Orsiro
arm group type: Active Comparator
description: Implantation of a Orsiro® biolimus a9 eluting coronary stent (drug-eluting stent, DES)
arm group label: Resolute Integrity
arm group type: Active Comparator
description: Implantation of a Resolute Integrity® zotarolimus eluting coronary stent (drug-eluting stent, DES)
intervention type: Device
intervention name: Orsiro stents
description: Percutaneous coronary intervention with implantation of either:
a Orsiro® biolimus a9 eluting coronary stent
arm group label: Orsiro
intervention type: Device
intervention name: Resolute Integrity® stents
description: Percutaneous coronary intervention with implantation of either:
a Resolute Integrity® zotarolimus eluting coronary stent
arm group label: Resolute Integrity
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bessonov S Ivan
role: Principal Investigator
affiliation: Tyumen Cardiology Research Center
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Angina Pectoris
mesh term: Angina, Stable
mesh term: Ischemia
provided document: 