<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/NCT03229993</url>
  </required_header>
  <id_info>
    <org_study_id>OCT-20170723</org_study_id>
    <nct_id>NCT03229993</nct_id>
  </id_info>
  <brief_title>OCT in Borderline Coronary Artery Lesions</brief_title>
  <official_title>The Safety and Efficacy of OCT in the Evaluation and Treatment of Angiographically Borderline Coronary Artery Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</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>
      To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation&#xD;
      and treatment of angiographically borderline coronary artery lesions in a Chinese population,&#xD;
      and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the&#xD;
      participants included in the study will be those that are found to have borderline coronary&#xD;
      artery lesions on coronary angiography, in whom the investigators feel that OCT will be&#xD;
      useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or&#xD;
      whether optimal medical therapy is the most appropriate treatment modality. Those&#xD;
      participants who declined OCT will be offered SPECT as an alternative method to assess and&#xD;
      treat the borderline coronary artery stenosis.&#xD;
&#xD;
      It is estimated that OCT guided &quot;PCI or not&quot; has a non-inferiority to SPECT's in the&#xD;
      borderline coronary artery stenosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 31, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MACEs</measure>
    <time_frame>12 months</time_frame>
    <description>The incidence of major adverse cardiac events (MACEs) including death, myocardial infarction, and stent thrombosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TLR</measure>
    <time_frame>12 months</time_frame>
    <description>The incidence of target lesion revascularization (TLR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rehospitalization</measure>
    <time_frame>12 months</time_frame>
    <description>The incidence of rehospitalization due to cardiac events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrent angina</measure>
    <time_frame>12 months</time_frame>
    <description>The incidence of recurrent angina</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Optical Coherence Tomography (OCT)</condition>
  <condition>Percutaneous Coronary Intervention (PCI)</condition>
  <condition>Single-Photon Emission Computed Tomography (SPECT)</condition>
  <condition>Coronary Angiography (CAG)</condition>
  <condition>Borderline Coronary Artery Lesions</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>OCT guided medicine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SPECT guided PCI</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SPECT guided medicine</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>OCT</intervention_name>
    <description>OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions</description>
    <arm_group_label>OCT guided PCI</arm_group_label>
    <arm_group_label>OCT guided medicine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The inclusion criteria for this study will be only those participants in whom&#xD;
             diagnostic coronary angiography revealed borderline coronary artery lesion. These&#xD;
             participants will undergo the OCT procedure, or alternatively ECT.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria will be those participants with previous cardiogenic shock, stroke,&#xD;
             renal dysfunction, and acute or chronic total occlusion coronary lesions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>First Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03229993
org study id: OCT-20170723
nct id: NCT03229993
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation
      and treatment of angiographically borderline coronary artery lesions in a Chinese population,
      and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the
      participants included in the study will be those that are found to have borderline coronary
      artery lesions on coronary angiography, in whom the investigators feel that OCT will be
      useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or
      whether optimal medical therapy is the most appropriate treatment modality. Those
      participants who declined OCT will be offered SPECT as an alternative method to assess and
      treat the borderline coronary artery stenosis.

      It is estimated that OCT guided "PCI or not" has a non-inferiority to SPECT's in the
      borderline coronary artery stenosis.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MACEs
time frame: 12 months
description: The incidence of major adverse cardiac events (MACEs) including death, myocardial infarction, and stent thrombosis.
measure: TLR
time frame: 12 months
description: The incidence of target lesion revascularization (TLR)
measure: Rehospitalization
time frame: 12 months
description: The incidence of rehospitalization due to cardiac events
measure: Recurrent angina
time frame: 12 months
description: The incidence of recurrent angina
arm group label: OCT guided PCI
arm group type: Experimental
arm group label: OCT guided medicine
arm group type: Experimental
arm group label: SPECT guided PCI
arm group type: No Intervention
arm group label: SPECT guided medicine
arm group type: No Intervention
intervention type: Diagnostic Test
intervention name: OCT
description: OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions
arm group label: OCT guided PCI
arm group label: OCT guided medicine
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
sharing ipd: Undecided