<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/NCT03809754</url>
  </required_header>
  <id_info>
    <org_study_id>Z171100001017158</org_study_id>
    <nct_id>NCT03809754</nct_id>
  </id_info>
  <brief_title>Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis</brief_title>
  <official_title>Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis: A Prospective Registry Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, registry trial aimed to compare the clinical and angiographic&#xD;
      outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>In-segment late loss at 9 months follow-up</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of acute success</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of 9-month binary restenosis</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with target lesion failure (TLF)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of major adverse cardiovascular events</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with all-cause death</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of myocardial infarction</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>CHD - Coronary Heart Disease</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <condition>In-stent Restenosis</condition>
  <arm_group>
    <arm_group_label>OCT-guided PCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Angiography-guided PCI</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Coronary Intervention under OCT</intervention_name>
    <description>After randomization, subjects receive primary PCI under the guiding of OCT</description>
    <arm_group_label>OCT-guided PCI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Coronary Intervention under Angiography</intervention_name>
    <description>After randomization, subjects receive primary PCI under the guiding of angiography</description>
    <arm_group_label>Angiography-guided PCI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Patients with angina or evidence of myocardial ischaemia&#xD;
&#xD;
          -  Patients with restenotic lesions in a previously DES area of a coronary artery&#xD;
&#xD;
          -  Patients suitable to receive any types of percutaneous coronary intervention&#xD;
             (including balloon angioplasty and stent implantation)&#xD;
&#xD;
          -  The stent diameter of DES-ISR is 2.5mm to 4.0mm&#xD;
&#xD;
          -  Target lesion length &lt; 30mm&#xD;
&#xD;
          -  Target lesion stenosis ≥ 70% diameter stenosis on visual assessment, or ≥ 50% diameter&#xD;
             stenosis and with evidence of myocardial ischaemia ischemic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with acute myocardial infarction with 1 week&#xD;
&#xD;
          -  Patients with evidence of extensive thrombosis in the target vessel&#xD;
&#xD;
          -  Patients with left main coronary artery disease&#xD;
&#xD;
          -  Patients with cardiogenic shock, left ventricular ejection fraction &lt; 40%,significant&#xD;
             renal dysfunction and severe heart valve disease&#xD;
&#xD;
          -  Patients who had cerebral stroke within 6 months before PCI&#xD;
&#xD;
          -  Patients with a life expectancy &lt; 1 year&#xD;
&#xD;
          -  Patients not able to adhere to follow-up visits&#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>Yundai Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yundai Chen</last_name>
    <phone>+8601055499135</phone>
    <email>yundaichen@vip.163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lei Gao</last_name>
    <email>nkgaolei2010@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Yundai Chen</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Yun Dai Chen</investigator_full_name>
    <investigator_title>Professor</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>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03809754
org study id: Z171100001017158
nct id: NCT03809754
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, registry trial aimed to compare the clinical and angiographic
      outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: In-segment late loss at 9 months follow-up
time frame: 9 months
measure: Rates of acute success
time frame: 1 month
measure: Rate of 9-month binary restenosis
time frame: 9 months
measure: Number of Participants with target lesion failure (TLF)
time frame: 12 months
measure: Rate of major adverse cardiovascular events
time frame: 12 months
measure: Number of participants with all-cause death
time frame: 12 months
measure: Rate of myocardial infarction
time frame: 12 months
arm group label: OCT-guided PCI
arm group type: Experimental
arm group label: Angiography-guided PCI
arm group type: Sham Comparator
intervention type: Procedure
intervention name: Percutaneous Coronary Intervention under OCT
description: After randomization, subjects receive primary PCI under the guiding of OCT
arm group label: OCT-guided PCI
intervention type: Procedure
intervention name: Percutaneous Coronary Intervention under Angiography
description: After randomization, subjects receive primary PCI under the guiding of angiography
arm group label: Angiography-guided PCI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yundai Chen
role: Principal Investigator
affiliation: Chinese PLA General Hospital
last name: Yundai Chen
phone: +8601055499135
email: yundaichen@vip.163.com
last name: Lei Gao
email: nkgaolei2010@126.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Yun Dai Chen
investigator title: Professor
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
sharing ipd: Undecided