<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/NCT01704911</url>
  </required_header>
  <id_info>
    <org_study_id>DRAGON</org_study_id>
    <nct_id>NCT01704911</nct_id>
  </id_info>
  <brief_title>Evaluate the Safety And Efficacy of the Transradial Coronary in Comparison With the Transfemoral Coronary Intervention</brief_title>
  <official_title>Determination of the Transradial Versus Transfemoral Coronary Angioplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CCRF Consulting Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Terumo Medical (Shanghai) Co.,Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>CCRF Consulting Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the DRAGON clinical trial is to evaluate the safety and efficacy of the&#xD;
      transradial coronary intervention (TRI) in comparison with the transfemoral coronary&#xD;
      intervention (TFI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Historically, performing PCI requires making an access to the peripheral arteries by an&#xD;
      arterial puncture or cutting down. This may lead to the serious bleeding complications&#xD;
      especially under the situation of dual antiplatelet therapy and/or potent anti-coagulation&#xD;
      therapies. TRI is now widely accepted as the most promising alternative for TFI around the&#xD;
      world. It is supposed to reduce the incidence of the serious bleeding complication during and&#xD;
      after PCI, as well as the total medical cost. There have been several prospective randomized&#xD;
      trials comparing the safety and efficacy between TRI and TFI, but none of them had enough&#xD;
      power to show the statistically valid equivalence in the efficacy between TRI and TFI. In&#xD;
      this study, investigators randomize approximately 1,700 patients into TRI or TFI.&#xD;
      Investigators adopt the rate of major adverse cardiac events (MACCE) at 1 year as the primary&#xD;
      efficacy endpoint for the study. Based on these rates at 1 year, the sample size for the&#xD;
      non-inferiority analysis for the primary efficacy endpoint is calculated. Through this&#xD;
      randomization trial, investigators can achieve the scientific evidence for the improved&#xD;
      safety and equal efficacy of TRI compared to TFI. This trial has enough statistical power to&#xD;
      draw the final conclusion in the debate between TRI and TFI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>major adverse cardiac or cerebrovascular events free rate</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the major bleeding complication (BARC definition type 3 or 5)-free rate</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1700</enrollment>
  <condition>Free Rate of Cardiac or Cerebrovascular Events</condition>
  <condition>Transradial-transfemoral Coronary Interventions Comparison</condition>
  <arm_group>
    <arm_group_label>Transradial Coronary Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transradial Coronary Intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transfemoral Coronary Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transfemoral Coronary Intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transradial Coronary Intervention</intervention_name>
    <arm_group_label>Transradial Coronary Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transfemoral Coronary Intervention</intervention_name>
    <arm_group_label>Transfemoral Coronary Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Coronary Stent System</intervention_name>
    <description>Any kind of coronary stent system</description>
    <arm_group_label>Transfemoral Coronary Intervention</arm_group_label>
    <arm_group_label>Transradial Coronary Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must be at least 18 years of age.&#xD;
&#xD;
          -  Patient is able to verbally acknowledge an understanding of the associated risks,&#xD;
             benefits and treatment alternatives and he or his legally authorized representative&#xD;
             provides signed informed consent prior to the randomization, as approved by the&#xD;
             appropriate IEC.&#xD;
&#xD;
          -  Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina,&#xD;
             silent ischemia, positive functional study or a reversible changes in the&#xD;
             electrocardiogram (ECG) consistent with ischemia).&#xD;
&#xD;
          -  Patient must be an acceptable candidate for coronary artery bypass graft (CABG)&#xD;
             surgery.&#xD;
&#xD;
          -  Allen test is required for suitable candidate.&#xD;
&#xD;
          -  Patient must agree to undergo all protocol-required follow-up examinations.&#xD;
&#xD;
          -  Patient must agree not to participate in any other clinical study within the duration&#xD;
             of this trial.&#xD;
&#xD;
          -  Target lesion must be able to be treated by using six-French guiding catheters.&#xD;
&#xD;
          -  Target lesion can be de Novo or restenotic.&#xD;
&#xD;
          -  The target lesion can be stable or unstable.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has received a heart transplant or any other organ transplant or is on a&#xD;
             waiting list for any organ transplant.&#xD;
&#xD;
          -  Patient is receiving or scheduled to receive chemotherapy for malignancy within 30&#xD;
             days prior to or after the procedure.&#xD;
&#xD;
          -  Patient is receiving immunosuppression therapy or has known immunosuppressive or&#xD;
             autoimmune disease (e.g. Human Immunodeficiency Virus, Lupus etc.).&#xD;
&#xD;
          -  Patient has extensive peripheral vascular disease that precludes safe 6 French sheath&#xD;
             insertion.&#xD;
&#xD;
          -  Patient has other medical illness (e.g., cancer or congestive heart failure) that may&#xD;
             cause non-compliance with the protocol, confound the data interpretation or is&#xD;
             associated with a limited life expectancy (i.e., less than one year).&#xD;
&#xD;
          -  Female patients of childbearing potential who have refused a urine or blood pregnancy&#xD;
             test (to be done within 7 days prior to index procedure), patients who are nursing at&#xD;
             the time of index procedure and those patients who do not agree at the time of consent&#xD;
             to use any approved form of birth control up to and including the follow-up at 1 year.&#xD;
&#xD;
          -  The target lesion is considered not to be treated by using six-French guiding&#xD;
             catheters.&#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>Shigeru Saito, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shonan Kamakura General Hospital, Japan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yong Huo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yong HUO, MD</last_name>
    <phone>861084059198</phone>
    <phone_ext>8528</phone_ext>
    <email>ybwang@ccrfmed.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yong Huo, MD</last_name>
      <phone>861084059198</phone>
      <phone_ext>8528</phone_ext>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 25, 2012</last_update_submitted>
  <last_update_submitted_qc>October 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transradial</keyword>
  <keyword>Transfemoral</keyword>
  <keyword>Coronary Intervention</keyword>
  <!-- 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/NCT01704911
org study id: DRAGON
nct id: NCT01704911
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of the DRAGON clinical trial is to evaluate the safety and efficacy of the
      transradial coronary intervention (TRI) in comparison with the transfemoral coronary
      intervention (TFI).
Historically, performing PCI requires making an access to the peripheral arteries by an
      arterial puncture or cutting down. This may lead to the serious bleeding complications
      especially under the situation of dual antiplatelet therapy and/or potent anti-coagulation
      therapies. TRI is now widely accepted as the most promising alternative for TFI around the
      world. It is supposed to reduce the incidence of the serious bleeding complication during and
      after PCI, as well as the total medical cost. There have been several prospective randomized
      trials comparing the safety and efficacy between TRI and TFI, but none of them had enough
      power to show the statistically valid equivalence in the efficacy between TRI and TFI. In
      this study, investigators randomize approximately 1,700 patients into TRI or TFI.
      Investigators adopt the rate of major adverse cardiac events (MACCE) at 1 year as the primary
      efficacy endpoint for the study. Based on these rates at 1 year, the sample size for the
      non-inferiority analysis for the primary efficacy endpoint is calculated. Through this
      randomization trial, investigators can achieve the scientific evidence for the improved
      safety and equal efficacy of TRI compared to TFI. This trial has enough statistical power to
      draw the final conclusion in the debate between TRI and TFI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: major adverse cardiac or cerebrovascular events free rate
time frame: one year
measure: the major bleeding complication (BARC definition type 3 or 5)-free rate
time frame: 7 days
arm group label: Transradial Coronary Intervention
arm group type: Experimental
description: Transradial Coronary Intervention
arm group label: Transfemoral Coronary Intervention
arm group type: Experimental
description: Transfemoral Coronary Intervention
intervention type: Procedure
intervention name: Transradial Coronary Intervention
arm group label: Transradial Coronary Intervention
intervention type: Procedure
intervention name: Transfemoral Coronary Intervention
arm group label: Transfemoral Coronary Intervention
intervention type: Device
intervention name: Coronary Stent System
description: Any kind of coronary stent system
arm group label: Transfemoral Coronary Intervention
arm group label: Transradial Coronary Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shigeru Saito, MD
role: Principal Investigator
affiliation: Shonan Kamakura General Hospital, Japan
last name: Yong Huo, MD
role: Principal Investigator
affiliation: Peking University First Hospital
last name: Yong HUO, MD
phone: 861084059198
phone ext: 8528
email: ybwang@ccrfmed.com
facility: 
contact: 
country: China
responsible party type: Sponsor