<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/NCT03300011</url>
  </required_header>
  <id_info>
    <org_study_id>2014ZDSYLL120.1</org_study_id>
    <nct_id>NCT03300011</nct_id>
  </id_info>
  <brief_title>Ultrasonic Cardiogram Evaluate the Prognosis of Percutaneous Revascularization of Chronic Total Occlusions</brief_title>
  <official_title>Ultrasonic Cardiogram to Evaluate the Long-term Outcome and Prognosis of Coronary Artery Chronic Total Occlusions for Percutaneous Revascularization Versus Optimal Medical Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</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>
      Chronic total occlusions (CTO) are encountered in almost one-fourth of patients undergoing&#xD;
      coronary angiography. The presence of an untreated CTO has been related to adverse clinical&#xD;
      prognosis, both in stable angina and acute myocardial infarction, and is often associated&#xD;
      with persistent symptomatic angina. Depending on their symptomatic and functional status as&#xD;
      well as anatomical complexity, CTO can be treated by optimal medical therapy only or therapy&#xD;
      combined with coronary revascularization. This study designed to evaluate the safety and&#xD;
      efficacy of coronary chronic total occlusion PCI by ultrasonic cardiogram.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      UCEPPCIOCT maintains a prospective clinical registry of all individual who undergo cardiac&#xD;
      angiography,PCI or optimistic medicine treatment.&#xD;
&#xD;
      1. research objective to observe the changes of cardiac function postoperative PCI in&#xD;
      patients with CTO and the incidence of major adverse cardiovascular events, and provide the&#xD;
      reality basis for PCI strategy in clinical patients with CTO . 2. research content: follow up&#xD;
      the patients with CTO by using echocardiography in preoperative and postoperative PCI in 1m,&#xD;
      3ms, 6ms, 12ms to assess the changes of cardiac structure and cardiac function. 2, comparison&#xD;
      the 'incidence of major adverse cardiovascular events undergo PCI treatment in success and&#xD;
      failure group in patients with CTO (such as severe angina attack, severe acute coronary&#xD;
      syndrome, severe heart failure should be rehospitalized , fatal arrhythmia and sudden cardiac&#xD;
      death, etc.)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Anticipated">October 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 1, 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>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>masking for Ultrasonic Cardiogram investigator</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>cardiac death,</measure>
    <time_frame>postoperation 1year</time_frame>
    <description>patients with CTO postoperative sudden death cause for acute myocardial infarction or severe arrhythmia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MACE</measure>
    <time_frame>postoperation 1year</time_frame>
    <description>recurrent severe angina, revascularization</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Coronary Chronic Total Occlusion</condition>
  <arm_group>
    <arm_group_label>recanalisation CTO lesion successful</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with CTO lesion performed PCI strategy and successfully recanalisation the CTO lesion with implanted stents .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>recanalisation CTO lesion failure</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients with CTO lesion performed PCI strategy and failure recanalisation the CTO lesion with PCI wire and balloon..</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OMT</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients with CTO lesion optimal medicine treatment without PCI</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>stent</intervention_name>
    <description>PTCA or PCI</description>
    <arm_group_label>recanalisation CTO lesion successful</arm_group_label>
    <other_name>Balloon</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        coronary artery of chronic total occlusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        ACS in 3months; once PCI or CABG; AF&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chen Lijuan, Ph.D</last_name>
    <phone>15295583256</phone>
    <email>chenlijuan@seu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ma Genshan, Ph.D</last_name>
    <phone>13002580569</phone>
    <email>magenshan@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zhongda Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weibing Shi, B.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Genshan Ma</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>ultrasonic</keyword>
  <keyword>chronic total occlusion</keyword>
  <keyword>heart function</keyword>
  <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/NCT03300011
org study id: 2014ZDSYLL120.1
nct id: NCT03300011
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Chronic total occlusions (CTO) are encountered in almost one-fourth of patients undergoing
      coronary angiography. The presence of an untreated CTO has been related to adverse clinical
      prognosis, both in stable angina and acute myocardial infarction, and is often associated
      with persistent symptomatic angina. Depending on their symptomatic and functional status as
      well as anatomical complexity, CTO can be treated by optimal medical therapy only or therapy
      combined with coronary revascularization. This study designed to evaluate the safety and
      efficacy of coronary chronic total occlusion PCI by ultrasonic cardiogram.
UCEPPCIOCT maintains a prospective clinical registry of all individual who undergo cardiac
      angiography,PCI or optimistic medicine treatment.

      1. research objective to observe the changes of cardiac function postoperative PCI in
      patients with CTO and the incidence of major adverse cardiovascular events, and provide the
      reality basis for PCI strategy in clinical patients with CTO . 2. research content: follow up
      the patients with CTO by using echocardiography in preoperative and postoperative PCI in 1m,
      3ms, 6ms, 12ms to assess the changes of cardiac structure and cardiac function. 2, comparison
      the 'incidence of major adverse cardiovascular events undergo PCI treatment in success and
      failure group in patients with CTO (such as severe angina attack, severe acute coronary
      syndrome, severe heart failure should be rehospitalized , fatal arrhythmia and sudden cardiac
      death, etc.)
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
masking description: masking for Ultrasonic Cardiogram investigator
measure: cardiac death,
time frame: postoperation 1year
description: patients with CTO postoperative sudden death cause for acute myocardial infarction or severe arrhythmia
measure: MACE
time frame: postoperation 1year
description: recurrent severe angina, revascularization
arm group label: recanalisation CTO lesion successful
arm group type: Experimental
description: Patients with CTO lesion performed PCI strategy and successfully recanalisation the CTO lesion with implanted stents .
arm group label: recanalisation CTO lesion failure
arm group type: No Intervention
description: Patients with CTO lesion performed PCI strategy and failure recanalisation the CTO lesion with PCI wire and balloon..
arm group label: OMT
arm group type: No Intervention
description: Patients with CTO lesion optimal medicine treatment without PCI
intervention type: Device
intervention name: stent
description: PTCA or PCI
arm group label: recanalisation CTO lesion successful
other name: Balloon
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Chen Lijuan, Ph.D
phone: 15295583256
email: chenlijuan@seu.edu.cn
last name: Ma Genshan, Ph.D
phone: 13002580569
email: magenshan@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Genshan Ma
investigator title: Director
sharing ipd: No