<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/NCT02215915</url>
  </required_header>
  <id_info>
    <org_study_id>20140729</org_study_id>
    <nct_id>NCT02215915</nct_id>
  </id_info>
  <brief_title>Intravascular Ultrasound Guided Drug Eluting Stents Implantation in &quot;All-comers&quot; Coronary Lesions （ULTIMATE Trial）</brief_title>
  <acronym>ULTIMATE</acronym>
  <official_title>Intravascular Ultrasound Guided Drug Eluting Stents Implantation in &quot;All-comers&quot; Coronary Lesions （ULTIMATE Trial）</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing First Hospital, Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing First Hospital, Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A number of 1448 patients scheduled for elective percutaneous coronary intervention (PCI)&#xD;
      with a native coronary stenosis suitable for DES implantation and IVUS imaging are openly&#xD;
      randomized 1:1 to either IVUS guidance or angiographic guidance groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is prospectively conducted at 8 high-volume PCI centers in China with IVUS&#xD;
      expertise. Clinic follow-up are planned in all patients 12 months after implantation of drug&#xD;
      eluting stents. Primary endpoint is target vessel failure. The study is powered for primary&#xD;
      endpoint, which are likely to reach significance at the level P &lt; 0.05 even at a follow-up&#xD;
      drop-out rate up to 10%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2014</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Target Vessel Failure</measure>
    <time_frame>12 months</time_frame>
    <description>The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>12 months</time_frame>
    <description>the occurrence of 1-year all cause death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death</measure>
    <time_frame>12 months</time_frame>
    <description>Death that could not be attributed to a noncardiac etiology was considered cardiac death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>12 months</time_frame>
    <description>Myocardial infarction was diagnosed by electrocardiographic changes and/or a rise and fall of creatine kinase-myocardial band fraction in the presence of ischemic symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel revascularization</measure>
    <time_frame>12 months</time_frame>
    <description>Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion revascularization</measure>
    <time_frame>12 months</time_frame>
    <description>Target lesion revascularization was defined as any revascularization procedure performed at the site of the treated lesion associated with clinical and/or objective evidence of inducible myocardial ischemia.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Stent thrombus</measure>
    <time_frame>12 months</time_frame>
    <description>Stent thrombus was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC).Regarding timing, ST was defined as early (&lt;30 days), late (30 days to 1 year), or too late (&gt;1 year).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1448</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>IVUS guided DES implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stent size and length were selected by online IVUS measurements, and adjunct high-pressure dilation was performed according to the discretion of operators based on the IVUS criteria for stent optimization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Angiography guided DES implantation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stent size and length were chosen by visual estimation, and adjunct high-pressure dilation was performed if an optimal result was not achieved, which was defined as angiographic residual diameter stenosis 20% and absence of angiographically detected dissection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Angiography</intervention_name>
    <description>The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm.</description>
    <arm_group_label>Angiography guided DES implantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IVUS</intervention_name>
    <description>The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results.</description>
    <arm_group_label>IVUS guided DES implantation</arm_group_label>
    <other_name>Intravascular ultrasound</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>DES implantation</intervention_name>
    <arm_group_label>Angiography guided DES implantation</arm_group_label>
    <arm_group_label>IVUS guided DES implantation</arm_group_label>
    <other_name>Percutaneous coronary drug-eluting stents implantation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of informed consent prior to any study specific procedures;&#xD;
&#xD;
          -  Men and women 18 years and older;.&#xD;
&#xD;
          -  Established indication to PCI according to the guidelines of American Heart&#xD;
             Association and American College of Cardiology;&#xD;
&#xD;
          -  Native coronary lesion suitable for drug-eluting stent placement and IVUS imaging.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and breast feeding mother;&#xD;
&#xD;
          -  Co-morbidity with an estimated life expectancy of &lt; 50 % at 12 months;&#xD;
&#xD;
          -  Scheduled major surgery in the next 12 months;&#xD;
&#xD;
          -  Inability to follow the protocol and comply with follow-up requirements or any other&#xD;
             reason that the investigator feels would place the patient at increased risk;&#xD;
&#xD;
          -  Previous enrolment in this study or treatment with an investigational drug or device&#xD;
             under another study protocol in the past 30 days;&#xD;
&#xD;
          -  Known allergy against ticagrelor, or against clopidogrel, or aspirin History of major&#xD;
             hemorrhage (intracranial, gastrointestinal, etc.);&#xD;
&#xD;
          -  Chronic total occlusion lesion in either LAD, or LCX or RCA not re-canalized;&#xD;
&#xD;
          -  Severe calcification needing rotational atherectomy；&#xD;
&#xD;
          -  Patient with STEMI (within 24-hour from the onset of chest pain to admission).&#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>Shaoliang Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanjing First Hospital, Nanjing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nanjing First Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>November 1, 2020</last_update_submitted>
  <last_update_submitted_qc>November 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing First Hospital, Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Shaoliang Chen</investigator_full_name>
    <investigator_title>Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital, Nanjing Medical University</investigator_title>
  </responsible_party>
  <keyword>Percutaneous coronary intervention</keyword>
  <keyword>Drug-eluting stent</keyword>
  <keyword>Intravascular ultrasound</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/NCT02215915
org study id: 20140729
nct id: NCT02215915
lead sponsor: 
has dmc: Yes
A number of 1448 patients scheduled for elective percutaneous coronary intervention (PCI)
      with a native coronary stenosis suitable for DES implantation and IVUS imaging are openly
      randomized 1:1 to either IVUS guidance or angiographic guidance groups.
The study is prospectively conducted at 8 high-volume PCI centers in China with IVUS
      expertise. Clinic follow-up are planned in all patients 12 months after implantation of drug
      eluting stents. Primary endpoint is target vessel failure. The study is powered for primary
      endpoint, which are likely to reach significance at the level P < 0.05 even at a follow-up
      drop-out rate up to 10%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Target Vessel Failure
time frame: 12 months
description: The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization.
measure: Mortality
time frame: 12 months
description: the occurrence of 1-year all cause death
measure: Cardiac death
time frame: 12 months
description: Death that could not be attributed to a noncardiac etiology was considered cardiac death.
measure: Myocardial infarction
time frame: 12 months
description: Myocardial infarction was diagnosed by electrocardiographic changes and/or a rise and fall of creatine kinase-myocardial band fraction in the presence of ischemic symptoms.
measure: Target vessel revascularization
time frame: 12 months
description: Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel.
measure: Target lesion revascularization
time frame: 12 months
description: Target lesion revascularization was defined as any revascularization procedure performed at the site of the treated lesion associated with clinical and/or objective evidence of inducible myocardial ischemia.
measure: Stent thrombus
time frame: 12 months
description: Stent thrombus was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC).Regarding timing, ST was defined as early (<30 days), late (30 days to 1 year), or too late (>1 year).
arm group label: IVUS guided DES implantation
arm group type: Experimental
description: Stent size and length were selected by online IVUS measurements, and adjunct high-pressure dilation was performed according to the discretion of operators based on the IVUS criteria for stent optimization.
arm group label: Angiography guided DES implantation
arm group type: Active Comparator
description: Stent size and length were chosen by visual estimation, and adjunct high-pressure dilation was performed if an optimal result was not achieved, which was defined as angiographic residual diameter stenosis 20% and absence of angiographically detected dissection.
intervention type: Procedure
intervention name: Angiography
description: The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm.
arm group label: Angiography guided DES implantation
intervention type: Procedure
intervention name: IVUS
description: The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results.
arm group label: IVUS guided DES implantation
other name: Intravascular ultrasound
intervention type: Procedure
intervention name: DES implantation
arm group label: Angiography guided DES implantation
arm group label: IVUS guided DES implantation
other name: Percutaneous coronary drug-eluting stents implantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shaoliang Chen, MD
role: Principal Investigator
affiliation: Nanjing First Hospital, Nanjing Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing First Hospital, Nanjing Medical University
investigator full name: Shaoliang Chen
investigator title: Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital, Nanjing Medical University
mesh term: Coronary Artery Disease
sharing ipd: No