<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/NCT03269461</url>
  </required_header>
  <id_info>
    <org_study_id>REPAIR</org_study_id>
    <nct_id>NCT03269461</nct_id>
  </id_info>
  <brief_title>Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation</brief_title>
  <acronym>REPAIR</acronym>
  <official_title>Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scitech Produtos Medicos Ltda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Scitech Produtos Medicos Ltda</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>
      Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in&#xD;
      patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first 20 patients enrolled will be evaluated by angiography and Optical Coherence&#xD;
      Tomography 3 months after stent implantation. The following 20 patients will be evaluated by&#xD;
      the same methods 2 months after the implantation and the last 20 patients after 30 days.&#xD;
&#xD;
      All patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index&#xD;
      procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tissue Coverage</measure>
    <time_frame>3 months</time_frame>
    <description>Change in the tissue coverage percentage measured by OCT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>in-stent late lumen loss</measure>
    <time_frame>3 months</time_frame>
    <description>in-stent late lumen loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Thrombosis</measure>
    <time_frame>2 years</time_frame>
    <description>Stent Thrombosis Rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Vessel Failure</measure>
    <time_frame>2 years</time_frame>
    <description>Target Vessel Failure (Death, MI and new revascularization)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>30 days evaluation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Angiography and Optical Coherence Tomography evaluations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 months evaluation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Angiography and Optical Coherence Tomography evaluations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 months evaluation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Angiography and Optical Coherence Tomography evaluations</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Angiography and Optical Coherence Tomography evaluations</intervention_name>
    <description>coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations</description>
    <arm_group_label>2 months evaluation</arm_group_label>
    <arm_group_label>3 months evaluation</arm_group_label>
    <arm_group_label>30 days evaluation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 and ≤ 80years;&#xD;
&#xD;
          -  Symptomatic CAD or documented myocardial ischemic disease;&#xD;
&#xD;
          -  Up to 2 de novo lesions on native coronary arteries;&#xD;
&#xD;
          -  Lesion length ≤ 29mm;&#xD;
&#xD;
          -  Reference vessel diameter between ≥2.5 and ≤ 3.5 mm;&#xD;
&#xD;
          -  Stenose at target lesion ≥ 70% and ≤ 99%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  STEMI within the last 72 hours pre-procedure;&#xD;
&#xD;
          -  renal insufficiency;&#xD;
&#xD;
          -  Left Main stenosis &gt; 50%;&#xD;
&#xD;
          -  Ostial lesions;&#xD;
&#xD;
          -  Bifurcation lesions with side branch ≥2mm;&#xD;
&#xD;
          -  More than one lesion &gt; 50% at the target vessel;&#xD;
&#xD;
          -  Left Ejection Fraction less than 30%;&#xD;
&#xD;
          -  Previous (less than 6 months) PCI at the target vessel.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Evangélico do Espírito Santo</name>
      <address>
        <city>Vila Velha</city>
        <state>Espírito Santo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital do Coração Anis Rassi</name>
      <address>
        <city>Goiânia</city>
        <state>Goiás</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paraná Medical Research Center</name>
      <address>
        <city>Maringá</city>
        <state>Paraná</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Cardiologia do Rio Grande do Sul</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Dante Pazzanese de Cardiologia</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>September 3, 2020</last_update_submitted>
  <last_update_submitted_qc>September 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stent, DES, INSPIRON, OCT, tissue repair</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03269461
org study id: REPAIR
nct id: NCT03269461
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in
      patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.
The first 20 patients enrolled will be evaluated by angiography and Optical Coherence
      Tomography 3 months after stent implantation. The following 20 patients will be evaluated by
      the same methods 2 months after the implantation and the last 20 patients after 30 days.

      All patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index
      procedure.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tissue Coverage
time frame: 3 months
description: Change in the tissue coverage percentage measured by OCT
measure: in-stent late lumen loss
time frame: 3 months
description: in-stent late lumen loss
measure: Stent Thrombosis
time frame: 2 years
description: Stent Thrombosis Rates
measure: Target Vessel Failure
time frame: 2 years
description: Target Vessel Failure (Death, MI and new revascularization)
arm group label: 30 days evaluation
arm group type: Experimental
description: Angiography and Optical Coherence Tomography evaluations
arm group label: 2 months evaluation
arm group type: Experimental
description: Angiography and Optical Coherence Tomography evaluations
arm group label: 3 months evaluation
arm group type: Experimental
description: Angiography and Optical Coherence Tomography evaluations
intervention type: Device
intervention name: Angiography and Optical Coherence Tomography evaluations
description: coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations
arm group label: 2 months evaluation
arm group label: 3 months evaluation
arm group label: 30 days evaluation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: No