<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/NCT01735110</url>
  </required_header>
  <id_info>
    <org_study_id>PREPARE</org_study_id>
    <nct_id>NCT01735110</nct_id>
  </id_info>
  <brief_title>PREPARE：Assessing the Safety and Efficacy of Radial Versus Femoral Approach PCI</brief_title>
  <acronym>PREPARE</acronym>
  <official_title>A Prospective, Multicenter, Randomized Trial Assessing the Safety and Efficacy of PCI Via Radial Versus Femoral Approach in Patients With Left Main and/or Three-Vessel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>CCRF Consulting Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese Academy of Medical Sciences, Fuwai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of PREPARE trial is to evaluate the long-term safety and efficacy of TRI versus&#xD;
      TFI for PCI in patients with left main (LM) and/or three-vessel coronary artery disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transradial intervention (TRI) has been widely practiced in China, accounting for approximate&#xD;
      80 to 90% of procedures. A recent meta-analysis indicated that TRI has advantages in reducing&#xD;
      major bleeding and ischemic events compared to transfemoral intervention (TFI) after the&#xD;
      percutaneous coronary intervention (PCI). However, no clinical trial has yet shown&#xD;
      statistical equivalence in terms of long-term efficacy of TRI compared with TFI for the&#xD;
      treatment of complex coronary lesions, which is simply due to limited numbers of subjects&#xD;
      enrolled. The purpose of PREPARE trial is to evaluate the long-term safety and efficacy of&#xD;
      TRI versus TFI for PCI in patients with left main (LM) and/or three-vessel coronary artery&#xD;
      disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 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 and cerebrovascular events (MACCE) at 12 months</measure>
    <time_frame>1 year</time_frame>
    <description>The primary endpoint is the major adverse cardiac and cerebrovascular events (MACCE) defined as the composite of all-caused death, all stroke, all myocardial infarction (MI), or any revascularization at 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure</measure>
    <time_frame>7 days</time_frame>
    <description>- The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Other outcomes</measure>
    <time_frame>5years</time_frame>
    <description>Death (Cardiac, Vascular, Non-cardiovascular)&#xD;
MI&#xD;
Stroke&#xD;
TLR (Ischemia-driven, not ischemia-driven) at 12 months&#xD;
TVR (Ischemia-driven, not ischemia-driven) at 12 months&#xD;
Stent thrombosis (per ARC definition) at 12 months&#xD;
Minor bleeding complication (BARC type 1 or 2) at 7 and 30 days&#xD;
Total bleeding complication (BARC definition) at 7 and 30 days&#xD;
PCI procedural success&#xD;
Device success&#xD;
Procedural or fluoro time&#xD;
Cross lesion failure rate&#xD;
Total procedure time&#xD;
Total amount of contrast use&#xD;
Total radiation doses&#xD;
Major vascular access site complication at discharge and 30 days post-procedure</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Transradial-transfemoral Coronary Interventions Comparison</condition>
  <arm_group>
    <arm_group_label>Femoral approach group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PCI through Femoral approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>radial approach group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PCI through radial approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transfemoral intervention (TFI)</intervention_name>
    <arm_group_label>Femoral approach group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transradial intervention</intervention_name>
    <arm_group_label>radial approach group</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 written 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;
          -  Patient with complex lesion who may need two or more than 2 stents implantation during&#xD;
             the indexed procedure is required surgeon's consultation before the operation. The&#xD;
             surgical consultation outcome must be recorded in detail.&#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;
        Angiographic inclusion criteria：&#xD;
&#xD;
          -  Target lesion must be able to be treated by using six-French guiding catheters.&#xD;
&#xD;
          -  Target lesion can be Left Main and/or Multivessel Diseases with Syntax score ≤32 for&#xD;
             LM and Syntax score ≤22 for MVD.&#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.&#xD;
&#xD;
          -  Patient is receiving immunosuppression therapy or has known immunosuppressive or&#xD;
             autoimmune disease (e.g. Human Immunodeficiency Virus, Lupus etc. Not include diabetes&#xD;
             mellitus).&#xD;
&#xD;
          -  Known hypersensitivity or contraindication to aspirin, zotarolimus, polymer, Nickel,&#xD;
             cobalt, chromium, iron, tungsten, etc. or stainless steel.&#xD;
&#xD;
          -  Patient has extensive peripheral vascular disease that precludes safely insertion of 6&#xD;
             French sheath.&#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;
          -  STEMI within 72h prior to procedure.&#xD;
&#xD;
          -  History of CABG.&#xD;
&#xD;
          -  Radial artery or femoral artery presence serious vascular bend or deformity that the&#xD;
             6F sheath can not go though.&#xD;
&#xD;
          -  Based on investigator's clinical judgments, high-risk patients, referring to predicted&#xD;
             procedural risks being higher than the procedural benefits must be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuejing Yang, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fuwai Hospital</affiliation>
  </overall_official>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>November 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>December 11, 2013</last_update_submitted>
  <last_update_submitted_qc>December 11, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
    <investigator_full_name>Yuejing Yang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01735110
org study id: PREPARE
nct id: NCT01735110
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of PREPARE trial is to evaluate the long-term safety and efficacy of TRI versus
      TFI for PCI in patients with left main (LM) and/or three-vessel coronary artery disease.
Transradial intervention (TRI) has been widely practiced in China, accounting for approximate
      80 to 90% of procedures. A recent meta-analysis indicated that TRI has advantages in reducing
      major bleeding and ischemic events compared to transfemoral intervention (TFI) after the
      percutaneous coronary intervention (PCI). However, no clinical trial has yet shown
      statistical equivalence in terms of long-term efficacy of TRI compared with TFI for the
      treatment of complex coronary lesions, which is simply due to limited numbers of subjects
      enrolled. The purpose of PREPARE trial is to evaluate the long-term safety and efficacy of
      TRI versus TFI for PCI in patients with left main (LM) and/or three-vessel coronary artery
      disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: major adverse cardiac and cerebrovascular events (MACCE) at 12 months
time frame: 1 year
description: The primary endpoint is the major adverse cardiac and cerebrovascular events (MACCE) defined as the composite of all-caused death, all stroke, all myocardial infarction (MI), or any revascularization at 12 months.
measure: The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure
time frame: 7 days
description: - The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure
measure: Other outcomes
time frame: 5years
description: Death (Cardiac, Vascular, Non-cardiovascular)
MI
Stroke
TLR (Ischemia-driven, not ischemia-driven) at 12 months
TVR (Ischemia-driven, not ischemia-driven) at 12 months
Stent thrombosis (per ARC definition) at 12 months
Minor bleeding complication (BARC type 1 or 2) at 7 and 30 days
Total bleeding complication (BARC definition) at 7 and 30 days
PCI procedural success
Device success
Procedural or fluoro time
Cross lesion failure rate
Total procedure time
Total amount of contrast use
Total radiation doses
Major vascular access site complication at discharge and 30 days post-procedure
arm group label: Femoral approach group
arm group type: Active Comparator
description: PCI through Femoral approach
arm group label: radial approach group
arm group type: Experimental
description: PCI through radial approach
intervention type: Procedure
intervention name: transfemoral intervention (TFI)
arm group label: Femoral approach group
intervention type: Procedure
intervention name: Transradial intervention
arm group label: radial approach group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yuejing Yang, Professor
role: Principal Investigator
affiliation: Fuwai Hospital
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
investigator full name: Yuejing Yang
investigator title: Professor