<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/NCT02237430</url>
  </required_header>
  <id_info>
    <org_study_id>CLOSE-UP III</org_study_id>
    <nct_id>NCT02237430</nct_id>
  </id_info>
  <brief_title>Randomized Comparison of MynxGrip Vascular Closure Device and Manual Compression for Closure After Femoral Access Angiography. The Closure Devices Used in Every Day Practice Study, CLOSE-UP III Trial</brief_title>
  <acronym>CLOSE-UP III</acronym>
  <official_title>Randomized Comparison of MynxGrip Vascular Closure Device and Manual Compression for Closure After Femoral Access Angiography. The Closure Devices Used in Every Day Practice Study, CLOSE-UP III Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital Skejby</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vingmed Danmark A/S</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aarhus University Hospital Skejby</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the&#xD;
      incidence of adverse access site related events in-hospital, at 30 days and at 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, randomized (1:1), controlled, non-blinded, single center study in 2000 patients&#xD;
      comparing the MynxGrip (test device) and manuel compression (standard comparator). Safety and&#xD;
      efficacy endpoints will be reported for in-hospital, 30 days and 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2014</start_date>
  <completion_date type="Actual">December 16, 2018</completion_date>
  <primary_completion_date type="Actual">May 16, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE)</measure>
    <time_frame>30 days</time_frame>
    <description>This includes: Major bleeding and/or blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery of leg, definitely or possible can be related to the closure procedure, infection needing antibiotics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time (min) to haemostasis</measure>
    <time_frame>30 days</time_frame>
    <description>From inserting the device (MynxGrip) until haemostasis and from beginning of manual compression to immediately haemostasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device failure</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vasovagal reaction until 5 minutes after end of closure procedure</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for new onset of manual compression</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain and discomfort related to the closure procedure</measure>
    <time_frame>Closure procedure and 30 days</time_frame>
    <description>Assessed on a numerical rating scale (NRS) from 0 (no pain or discomfort) to 10 (worst possible pain or discomfort).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to mobilization</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 2 days</time_frame>
    <description>From start of closure procedure to patient is mobilised.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital large groin haematoma</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 days</time_frame>
    <description>Larger than 5 x 5 cm measured by ruler in the catheterisation laboratory or at discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleedings according to the Bleeding Academic Research Consortium (BARC) definitions</measure>
    <time_frame>1 hour and 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major bleeding and/or bleeding necessitation blood transfusion</measure>
    <time_frame>30 days and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pseudoaneurysm with indication for treatment</measure>
    <time_frame>30 days and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arteriovenous fistula</measure>
    <time_frame>30 days and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Groin surgery and/or possible related vascular surgery</measure>
    <time_frame>30 days and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection needing antibiotics</measure>
    <time_frame>30 days and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for medical evaluation of possible closure procedure related symptom(s)</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">869</enrollment>
  <condition>Coronary Disease</condition>
  <arm_group>
    <arm_group_label>Manuel compression</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional manual compression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MynxGrip closure device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Closure device for femoral artery access closure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MynxGrip</intervention_name>
    <description>Closure device for femoral artery access closure</description>
    <arm_group_label>MynxGrip closure device</arm_group_label>
    <other_name>Closure device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual compression</intervention_name>
    <description>Conventional manual compression</description>
    <arm_group_label>Manuel compression</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 year&#xD;
&#xD;
          -  Should be able to provide valid informed signed consent&#xD;
&#xD;
          -  CAG, possibly including intracoronary measurement (FFR) or intracoronary imaging&#xD;
             (IVUS, optical coherence tomography (OCT), NIRS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Percutaneous coronary intervention (PCI) procedure and/or implantation of stents&#xD;
&#xD;
          -  ST-Elevations Myocardial Infarction (STEMI)&#xD;
&#xD;
          -  Multiple punctures&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Groin haematoma before the closure procedure&#xD;
&#xD;
          -  Known pseudoaneurysm or arteriovenous (AV) fistula in the ipsilateral groin&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Prior peripheral arterial surgery in abdomen or lower extremities&#xD;
&#xD;
          -  Sheat size &gt;7 F&#xD;
&#xD;
          -  Life expectancy less than one year&#xD;
&#xD;
          -  Possible pregnancy or positive pregnancy test or breastfeeding women&#xD;
&#xD;
          -  Simultaneous or planned subsequent femoral vein access&#xD;
&#xD;
          -  Allergy to any of the components in the closure material left in the groin&#xD;
&#xD;
          -  Puncture or closure with closure device at same site &lt; 30 days&#xD;
&#xD;
          -  Puncture or closure with manuel compression at same site &lt; 5 days&#xD;
&#xD;
          -  Patients with peripheral artery disease can be included at operators discretion except&#xD;
             if heavy calcification is present at the access site, which at the operators&#xD;
             discretion precludes insertion of the closure device&#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>Evald H Christiansen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>May 7, 2019</last_update_submitted>
  <last_update_submitted_qc>May 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital Skejby</investigator_affiliation>
    <investigator_full_name>Evald Hoej Christiansen</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Coronary angiography (CAG)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT02237430
org study id: CLOSE-UP III
nct id: NCT02237430
lead sponsor: 
collaborator: 
has dmc: Yes
Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the
      incidence of adverse access site related events in-hospital, at 30 days and at 6 months.
Prospective, randomized (1:1), controlled, non-blinded, single center study in 2000 patients
      comparing the MynxGrip (test device) and manuel compression (standard comparator). Safety and
      efficacy endpoints will be reported for in-hospital, 30 days and 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE)
time frame: 30 days
description: This includes: Major bleeding and/or blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery of leg, definitely or possible can be related to the closure procedure, infection needing antibiotics.
measure: Time (min) to haemostasis
time frame: 30 days
description: From inserting the device (MynxGrip) until haemostasis and from beginning of manual compression to immediately haemostasis
measure: Device failure
time frame: 30 minutes
measure: Vasovagal reaction until 5 minutes after end of closure procedure
time frame: 30 minutes
measure: Need for new onset of manual compression
time frame: 30 days
measure: Pain and discomfort related to the closure procedure
time frame: Closure procedure and 30 days
description: Assessed on a numerical rating scale (NRS) from 0 (no pain or discomfort) to 10 (worst possible pain or discomfort).
measure: Time to mobilization
time frame: participants will be followed for the duration of hospital stay, an expected average of 2 days
description: From start of closure procedure to patient is mobilised.
measure: In-hospital large groin haematoma
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
description: Larger than 5 x 5 cm measured by ruler in the catheterisation laboratory or at discharge
measure: Bleedings according to the Bleeding Academic Research Consortium (BARC) definitions
time frame: 1 hour and 30 days
measure: Major bleeding and/or bleeding necessitation blood transfusion
time frame: 30 days and 6 months
measure: Pseudoaneurysm with indication for treatment
time frame: 30 days and 6 months
measure: Arteriovenous fistula
time frame: 30 days and 6 months
measure: Groin surgery and/or possible related vascular surgery
time frame: 30 days and 6 months
measure: Infection needing antibiotics
time frame: 30 days and 6 months
measure: Need for medical evaluation of possible closure procedure related symptom(s)
time frame: 30 days
arm group label: Manuel compression
arm group type: Active Comparator
description: Conventional manual compression
arm group label: MynxGrip closure device
arm group type: Experimental
description: Closure device for femoral artery access closure
intervention type: Device
intervention name: MynxGrip
description: Closure device for femoral artery access closure
arm group label: MynxGrip closure device
other name: Closure device
intervention type: Other
intervention name: Manual compression
description: Conventional manual compression
arm group label: Manuel compression
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evald H Christiansen, MD
role: Principal Investigator
affiliation: Aarhus University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital Skejby
investigator full name: Evald Hoej Christiansen
investigator title: MD
mesh term: Coronary Disease