<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/NCT04444960</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AF-CRF-2019-014</org_study_id>
    <nct_id>NCT04444960</nct_id>
  </id_info>
  <brief_title>Precision Therapy in Complex High-risk Coronary Artery Disease</brief_title>
  <acronym>PTCA</acronym>
  <official_title>Prospective Registry of the Intracoronary Physiology and Imaging-guided Precision Therapy in Complex High-risk Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong 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>
      This is a prospective registry to enroll complex high-risk coronary heart disease patients.&#xD;
&#xD;
      The purpose of this study is to compare intracoronary physiology and imaging-guided&#xD;
      intervention strategy and angiography-guided intervention strategy for clinical outcomes and&#xD;
      health economics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>24 Months</target_duration>
  <primary_outcome>
    <measure>Composite ischemic events</measure>
    <time_frame>24 months</time_frame>
    <description>Composite ischemic event is defined as the composite of cardiac death, stent thrombosis, nonfatal myocardial infarction or ischemic driven revascularization.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Intracoronary physiology and imaging-guided group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Angiography-guided group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>percutaneous coronary intervention</intervention_name>
    <description>Intracoronary physiology and imaging-guided intervention strategy versus angiography-guided intervention strategy for complex high-risk coronary heart disease patients</description>
    <arm_group_label>Angiography-guided group</arm_group_label>
    <arm_group_label>Intracoronary physiology and imaging-guided group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Coronary heart disease patients with complicated clinical conditions and/or complex&#xD;
        coronary lesions.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bifurcation lesions with branch diameter ≥2.5mm;&#xD;
&#xD;
          -  Chronic complete occlusion (occlusion duration ≥3 months);&#xD;
&#xD;
          -  Left main disease;&#xD;
&#xD;
          -  Long lesions (≥38mm);&#xD;
&#xD;
          -  Multi-vessel percutaneous coronary intervention (simultaneous treatment of ≥2&#xD;
             epicardial vessels during one operation);&#xD;
&#xD;
          -  Multi-stent implantation (≥3 stents);&#xD;
&#xD;
          -  In-stent restenosis;&#xD;
&#xD;
          -  Moderate to severe calcification on radiography;&#xD;
&#xD;
          -  Intermediate lesion;&#xD;
&#xD;
          -  Thrombotic lesions;&#xD;
&#xD;
          -  Creatinine clearance rate &lt; 60ml/min) or on dialysis ;&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt;40% ；&#xD;
&#xD;
          -  History of cerebral hemorrhage or massive hemorrhage of gastrointestinal tract.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Informed consent cannot be obtained;&#xD;
&#xD;
          -  Life expectancy &lt; 1 year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xin Huang, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xin Huang, PhD</last_name>
    <phone>008613571961135</phone>
    <email>hearthx@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xin Huang, phD</last_name>
      <phone>008613571961135</phone>
      <email>hearthx@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>August 19, 2020</last_update_submitted>
  <last_update_submitted_qc>August 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2020</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>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</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/NCT04444960
org study id: XJTU1AF-CRF-2019-014
nct id: NCT04444960
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective registry to enroll complex high-risk coronary heart disease patients.

      The purpose of this study is to compare intracoronary physiology and imaging-guided
      intervention strategy and angiography-guided intervention strategy for clinical outcomes and
      health economics.
observational model: Case-Only
time perspective: Prospective
measure: Composite ischemic events
time frame: 24 months
description: Composite ischemic event is defined as the composite of cardiac death, stent thrombosis, nonfatal myocardial infarction or ischemic driven revascularization.
arm group label: Intracoronary physiology and imaging-guided group
arm group label: Angiography-guided group
intervention type: Procedure
intervention name: percutaneous coronary intervention
description: Intracoronary physiology and imaging-guided intervention strategy versus angiography-guided intervention strategy for complex high-risk coronary heart disease patients
arm group label: Angiography-guided group
arm group label: Intracoronary physiology and imaging-guided group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Xin Huang, phD
role: Principal Investigator
affiliation: First Affiliated Hospital Xi'an Jiaotong University
last name: Xin Huang, PhD
phone: 008613571961135
email: hearthx@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease