xml: <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/NCT06009757</url>
    </required_header>
    <id_info>
      <org_study_id>CLI-00910</org_study_id>
      <nct_id>NCT06009757</nct_id>
    </id_info>
    <brief_title>GUIDEX® Versus Launcher™ Guiding Catheter in Percutaneous Coronary Intervention (PCI)</brief_title>
    <acronym>GUIDEX®_FR</acronym>
    <official_title>Safety and Efficacy of the GUIDEX® Versus Launcher™ Guiding Catheter in Adults' Patients With Coronary Artery Disease (CAD) Requiring Percutaneous Coronary Intervention (PCI): a Non-inferiority and Randomized, Clinical Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing Demax Medical Technology Co.,Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>CEISO</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Beijing Demax Medical Technology Co.,Ltd</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>
        The goal of this clinical trial is to compare two guiding catheters in patients with coronary&#xD;
        artery disease during a percutaneous coronary intervention between Guidex® Guiding catheter&#xD;
        (DEMAX) and Launcher™ coronary guide catheters (Medtronic). The main question[s] it aims to&#xD;
        answer are:&#xD;
  &#xD;
          -  Aren't the safety of medical devices inferior to each other?&#xD;
  &#xD;
          -  Aren't the efficacyof medical devices inferior to each other? Participants will be&#xD;
             randomized (1:1) and have a percutaneous coronary interventionwith one of the two&#xD;
             guiding catheters.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cardiovascular disease (CVD) remains the most common cause of death in the European region.&#xD;
        In line with the Global Burden of Disease (GBD) estimates from 2001, 43% of all Cardio&#xD;
        Vascular Disease (CVD) deaths are related to coronary artery disease (CAD).&#xD;
  &#xD;
        Treatment of CAD is always based on medication, which may also be supplemented by invasive&#xD;
        procedures. The most significant historical advances in the treatment of coronary artery&#xD;
        disease were the development of coronary artery bypass grafting (CABG) and percutaneous&#xD;
        coronary intervention (PCI).&#xD;
  &#xD;
        An essential element in the success of an angioplasty and in shortening the procedure, the&#xD;
        guiding catheter is not simply a support. While, it's primary role is designed to provide a&#xD;
        pathway through which balloon dilation catheter, guide wire or other devices are introduced,&#xD;
        it can also contribute to significant semantic information since it is the first tool to&#xD;
        appear in the field of view. A variety of guiding catheter references are available on the&#xD;
        market.&#xD;
  &#xD;
        Guiding catheters of various sizes and shapes are selected based on vessel anatomy, lesion&#xD;
        characteristics, vascular access and procedural complexity.&#xD;
  &#xD;
        The GUIDEX® device is a guiding catheter designed to be used in percutaneous coronary&#xD;
        intervention. GUIDEX® device is on the Chinese market since September 2015 (certificate&#xD;
        renewal in 2020) and is presented for CE marking according to MDR 2017/745.&#xD;
  &#xD;
        The aim of the study is to assess the essential requirements for CE marking of Guidex®: the&#xD;
        efficacy and safety of the device. Thus the aim of this non-inferiority study is to compare&#xD;
        the efficacy and safety for patients with coronary artery disease during a percutaneous&#xD;
        coronary intervention between Guidex® Guiding catheter (DEMAX) and Launcher™ coronary guide&#xD;
        catheters (Medtronic).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">November 2023</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>
      <intervention_model_description>Thus the aim of this non-inferiority study is to compare the efficacy and safety for patients with coronary artery disease during a percutaneous coronary intervention between Guidex® Guiding catheter (DEMAX) and Launcher™ coronary guide catheters (Medtronic).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>The study is single-blind. The patient does not know which guidance catheter will be used.&#xD;
  Due to the nature of the intervention (different form of guiding catheter), staff may not be blind to the allocation, but they are strongly encouraged not to disclose the participant's allocation status during follow-up assessments. The sponsor's team will not know what type of treatment the patient's number corresponds to. Under no circumstances will they have access to the list of matches between the patient number and the allocated treatment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The primary outcome is the frequency of in-hospital major adverse cardiac events (MACE)</measure>
      <time_frame>Baseline until the end of the procedure</time_frame>
      <description>Analyze the frequency of major adverse cardiac events (MACE) during the procedure. MACE was defined as the following:&#xD;
  Cardiac death&#xD;
  Myocardial infarction - defined as a CK-MB level &gt; 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave&#xD;
  TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of subjects achieving angiographic with sucess</measure>
      <time_frame>Baseline until End of the procedure</time_frame>
      <description>The percentage of subjects achieving angiographic success were defined as success in facilating delivery of the balloon dilation catheter, guidewire or other devices introduced in the coronary arteries, using the medical devices with &lt;50% residual stenosis without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F - To confirm ), perforation, abrupt closure, and persistent slow flow or persistent no reflow.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of in-hospital major adverse cardiac events (MACE). MACE was defined as the following: a composite of cardiac death, myocardial infarction, and target lesion revascularization.</measure>
      <time_frame>Baseline until discharge from the hospital (Day 2)</time_frame>
      <description>Analyze the frequency of in-hospital major adverse cardiac events (MACE). MACE was defined as the following:&#xD;
  Cardiac death&#xD;
  Myocardial infarction - defined as a CK-MB level &gt; 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave&#xD;
  TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of complication and adverse event rates</measure>
      <time_frame>[Time frame; to the baseline up to 30 days after the procedure)</time_frame>
      <description>Incidence of adverse event during 1 month after the PCI (in particular related to the potential adverse event at the puncture site).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time used for the procedure (in minutes) .</measure>
      <time_frame>Baseline until end of the procedure (Day 1)</time_frame>
      <description>Time (in minutes) between the start of the procedure until the end of the procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of access-site-related complications.</measure>
      <time_frame>Baseline until End of the procedure</time_frame>
      <description>The frequency of access-site related complications is defined as bleeding, pseudoaneurysm, arteriovenous fistula, and occlusion of the radial artery), which were considered to be major if they were associated with a vascular repair or a blood transfusion.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>Percutaneous Coronary Intervention with Guiding Catheter GUIDEX</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Percutaneous Coronary Intervention with Guiding Catheter Medtronics</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>GUIDEX® guiding catheter</intervention_name>
      <description>The main steps of the procedure Percutaneous Coronary Intervention are :&#xD;
  The patient should prepare for angioplasty using standard techniques. Appropriate anticoagulation and vasodilation therapy should be administered.&#xD;
  The Guiding Catheter must be introduced into the vascular system by cut-down or percutaneous techniques.&#xD;
  The guiding catheter will be introduce over a previously placed standard angiographic wire. It will be aspirate and flush after the removal of the angiographic wire following established angiographic technique.&#xD;
  The catheter should should address the selected vascular site&#xD;
  The guiding catheter will be removing. The procedure is performed in a healthcare facility, in an operating room under fluoroscopic monitoring. The users are trained practiticoners for PCI.</description>
      <arm_group_label>Percutaneous Coronary Intervention with Guiding Catheter GUIDEX</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Launcher™ coronary guide catheter</intervention_name>
      <description>The main steps of the procedure Percutaneous Coronary Intervention are :&#xD;
  The patient should prepare for angioplasty using standard techniques. Appropriate anticoagulation and vasodilation therapy should be administered.&#xD;
  The Guiding Catheter must be introduced into the vascular system by cut-down or percutaneous techniques.&#xD;
  The guiding catheter will be introduce over a previously placed standard angiographic wire. It will be aspirate and flush after the removal of the angiographic wire following established angiographic technique.&#xD;
  The catheter should should address the selected vascular site&#xD;
  The guiding catheter will be removing. The procedure is performed in a healthcare facility, in an operating room under fluoroscopic monitoring. The users are trained practiticoners for PCI.</description>
      <arm_group_label>Percutaneous Coronary Intervention with Guiding Catheter Medtronics</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Patients need to be at least 18 years old.&#xD;
  &#xD;
                 -  Patients presenting with a significant coronary artery disease who qualify for&#xD;
                    PCI and who can be treated by a radial and femoral approach.&#xD;
  &#xD;
                 -  Patients scheduled for surgery&#xD;
  &#xD;
                 -  The target vessel must have a TIMI flow 3 at baseline&#xD;
  &#xD;
                 -  Diagnostic and therapeutic intervention performed through trans-radial or&#xD;
                    trans-femoral artery approach.&#xD;
  &#xD;
                 -  Palpable radial or fermoral artery&#xD;
  &#xD;
                 -  Patients covered by the social security system&#xD;
  &#xD;
                 -  Troponin must be less than or equal to the upper limit of lab normal value within&#xD;
                    24 hours prior to the procedure OR if troponin is elevated, concomitant CK must&#xD;
                    be normal.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Challenging vessel anatomy,&#xD;
  &#xD;
                 -  Concomitant use of Atherectomy, specialty balloon, or investigational coronary&#xD;
                    devices&#xD;
  &#xD;
                 -  Active bleeding or significant increased risk of bleeding, severe hepatic&#xD;
                    insufficiency, current peptic ulceration, proliferative diabetic retinopathy.&#xD;
  &#xD;
                 -  Prior PCI procedure within the last 30 days of the index procedure&#xD;
  &#xD;
                 -  Current platelet count &lt;100 x 10^9cells/L or Hgb &lt;10 g/dL.&#xD;
  &#xD;
                 -  Uncontrolled severe hypertension (systolic BP &gt;180 mm Hg or diastolic BP &gt;110 mm&#xD;
                    Hg)&#xD;
  &#xD;
                 -  Target vessel &lt; 2.4 mm in diameter&#xD;
  &#xD;
                 -  Target lesion &gt; 32 mm in length&#xD;
  &#xD;
                 -  Patient has allergy to imaging contrast media for which they cannot be&#xD;
                    pre-medicated&#xD;
  &#xD;
                 -  Patients with hypersensitivity or contraindication to antiplatelet treatment&#xD;
  &#xD;
                 -  Patient unable to stop his or her daily oral medication includes metformin&#xD;
                    treatment during X days.&#xD;
  &#xD;
                 -  Unable to follow the requirements of the protocol.&#xD;
  &#xD;
                 -  Vulnerable: whose ability or freedom to give or refuse consent is limited.&#xD;
  &#xD;
                 -  Patients who cannot read or write french;&#xD;
  &#xD;
                 -  Major person benefiting from a legal protection regime (guardianship,&#xD;
                    curatorship, safeguard of justice);&#xD;
  &#xD;
                 -  Patient is pregnant or nursing&#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_contact>
      <last_name>Clement SERVOZ, Dr</last_name>
      <phone>+33 5 61 32 24 31</phone>
      <email>servoz.c@chu-toulouse.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Thibault Lhermusier, Pr</last_name>
      <email>lhermusier.t@chu-toulouse.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHU Toulouse</name>
        <address>
          <city>Toulouse</city>
          <zip>31300</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Clement Servoz, Dr</last_name>
        <phone>+33 5 61 32 24 31</phone>
        <email>servoz.c@chu-toulouse.fr</email>
      </contact>
      <contact_backup>
        <last_name>Thibault Lhermusier, Pr</last_name>
        <email>lhermusier.t@chu-toulouse.fr</email>
      </contact_backup>
      <investigator>
        <last_name>Clement SERVOZ, Dr</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Thibault Lhermusier, Pr</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Percutaneous coronary intervention</keyword>
    <keyword>Guiding catheter</keyword>
    <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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Nothing</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009757
  org study id: CLI-00910
  nct id: NCT06009757
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare two guiding catheters in patients with coronary
        artery disease during a percutaneous coronary intervention between Guidex® Guiding catheter
        (DEMAX) and Launcher™ coronary guide catheters (Medtronic). The main question[s] it aims to
        answer are:
  
          -  Aren't the safety of medical devices inferior to each other?
  
          -  Aren't the efficacyof medical devices inferior to each other? Participants will be
             randomized (1:1) and have a percutaneous coronary interventionwith one of the two
             guiding catheters.
  Cardiovascular disease (CVD) remains the most common cause of death in the European region.
        In line with the Global Burden of Disease (GBD) estimates from 2001, 43% of all Cardio
        Vascular Disease (CVD) deaths are related to coronary artery disease (CAD).
  
        Treatment of CAD is always based on medication, which may also be supplemented by invasive
        procedures. The most significant historical advances in the treatment of coronary artery
        disease were the development of coronary artery bypass grafting (CABG) and percutaneous
        coronary intervention (PCI).
  
        An essential element in the success of an angioplasty and in shortening the procedure, the
        guiding catheter is not simply a support. While, it's primary role is designed to provide a
        pathway through which balloon dilation catheter, guide wire or other devices are introduced,
        it can also contribute to significant semantic information since it is the first tool to
        appear in the field of view. A variety of guiding catheter references are available on the
        market.
  
        Guiding catheters of various sizes and shapes are selected based on vessel anatomy, lesion
        characteristics, vascular access and procedural complexity.
  
        The GUIDEX® device is a guiding catheter designed to be used in percutaneous coronary
        intervention. GUIDEX® device is on the Chinese market since September 2015 (certificate
        renewal in 2020) and is presented for CE marking according to MDR 2017/745.
  
        The aim of the study is to assess the essential requirements for CE marking of Guidex®: the
        efficacy and safety of the device. Thus the aim of this non-inferiority study is to compare
        the efficacy and safety for patients with coronary artery disease during a percutaneous
        coronary intervention between Guidex® Guiding catheter (DEMAX) and Launcher™ coronary guide
        catheters (Medtronic).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Thus the aim of this non-inferiority study is to compare the efficacy and safety for patients with coronary artery disease during a percutaneous coronary intervention between Guidex® Guiding catheter (DEMAX) and Launcher™ coronary guide catheters (Medtronic).
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: The study is single-blind. The patient does not know which guidance catheter will be used.
  Due to the nature of the intervention (different form of guiding catheter), staff may not be blind to the allocation, but they are strongly encouraged not to disclose the participant's allocation status during follow-up assessments. The sponsor's team will not know what type of treatment the patient's number corresponds to. Under no circumstances will they have access to the list of matches between the patient number and the allocated treatment.
  measure: The primary outcome is the frequency of in-hospital major adverse cardiac events (MACE)
  time frame: Baseline until the end of the procedure
  description: Analyze the frequency of major adverse cardiac events (MACE) during the procedure. MACE was defined as the following:
  Cardiac death
  Myocardial infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave
  TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
  measure: Percentage of subjects achieving angiographic with sucess
  time frame: Baseline until End of the procedure
  description: The percentage of subjects achieving angiographic success were defined as success in facilating delivery of the balloon dilation catheter, guidewire or other devices introduced in the coronary arteries, using the medical devices with <50% residual stenosis without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F - To confirm ), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
  measure: Frequency of in-hospital major adverse cardiac events (MACE). MACE was defined as the following: a composite of cardiac death, myocardial infarction, and target lesion revascularization.
  time frame: Baseline until discharge from the hospital (Day 2)
  description: Analyze the frequency of in-hospital major adverse cardiac events (MACE). MACE was defined as the following:
  Cardiac death
  Myocardial infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave
  TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
  measure: Incidence of complication and adverse event rates
  time frame: [Time frame; to the baseline up to 30 days after the procedure)
  description: Incidence of adverse event during 1 month after the PCI (in particular related to the potential adverse event at the puncture site).
  measure: Time used for the procedure (in minutes) .
  time frame: Baseline until end of the procedure (Day 1)
  description: Time (in minutes) between the start of the procedure until the end of the procedure
  measure: Frequency of access-site-related complications.
  time frame: Baseline until End of the procedure
  description: The frequency of access-site related complications is defined as bleeding, pseudoaneurysm, arteriovenous fistula, and occlusion of the radial artery), which were considered to be major if they were associated with a vascular repair or a blood transfusion.
  arm group label: Percutaneous Coronary Intervention with Guiding Catheter GUIDEX
  arm group type: Experimental
  description: Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter
  arm group label: Percutaneous Coronary Intervention with Guiding Catheter Medtronics
  arm group type: Experimental
  description: Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter
  intervention type: Device
  intervention name: GUIDEX® guiding catheter
  description: The main steps of the procedure Percutaneous Coronary Intervention are :
  The patient should prepare for angioplasty using standard techniques. Appropriate anticoagulation and vasodilation therapy should be administered.
  The Guiding Catheter must be introduced into the vascular system by cut-down or percutaneous techniques.
  The guiding catheter will be introduce over a previously placed standard angiographic wire. It will be aspirate and flush after the removal of the angiographic wire following established angiographic technique.
  The catheter should should address the selected vascular site
  The guiding catheter will be removing. The procedure is performed in a healthcare facility, in an operating room under fluoroscopic monitoring. The users are trained practiticoners for PCI.
  arm group label: Percutaneous Coronary Intervention with Guiding Catheter GUIDEX
  intervention type: Device
  intervention name: Launcher™ coronary guide catheter
  description: The main steps of the procedure Percutaneous Coronary Intervention are :
  The patient should prepare for angioplasty using standard techniques. Appropriate anticoagulation and vasodilation therapy should be administered.
  The Guiding Catheter must be introduced into the vascular system by cut-down or percutaneous techniques.
  The guiding catheter will be introduce over a previously placed standard angiographic wire. It will be aspirate and flush after the removal of the angiographic wire following established angiographic technique.
  The catheter should should address the selected vascular site
  The guiding catheter will be removing. The procedure is performed in a healthcare facility, in an operating room under fluoroscopic monitoring. The users are trained practiticoners for PCI.
  arm group label: Percutaneous Coronary Intervention with Guiding Catheter Medtronics
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clement SERVOZ, Dr
  phone: +33 5 61 32 24 31
  email: servoz.c@chu-toulouse.fr
  last name: Thibault Lhermusier, Pr
  email: lhermusier.t@chu-toulouse.fr
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  sharing ipd: No
  ipd description: Nothing