<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/NCT02234830</url>
  </required_header>
  <id_info>
    <org_study_id>1-10-72-68-12</org_study_id>
    <nct_id>NCT02234830</nct_id>
  </id_info>
  <brief_title>Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial</brief_title>
  <acronym>CLOSE-UP II</acronym>
  <official_title>Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital Skejby</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cordis Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Aarhus University Hospital Skejby</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence&#xD;
      of adverse access site related events at 30 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, randomized (1:1) controlled, single blind, single center study in 2000&#xD;
      percutaneous coronary intervention (PCI) patients comparing the ExoSeal VCD (test device) to&#xD;
      the AngioSeal VCD (standard comparator). In-hospital and 30 days safety and efficacy&#xD;
      endpoints and 6 months safety endpoints will be reported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2012</start_date>
  <completion_date type="Actual">May 14, 2017</completion_date>
  <primary_completion_date type="Actual">May 14, 2016</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 access site related major adverse vascular events (MAVE)</measure>
    <time_frame>30 days</time_frame>
    <description>This includes: major bleeding and/or bleeding necessitating blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery and/or possible related vascular surgery, infection needing antibiotics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to haemostasis from removing the sheath (AngioSeal) or inserting the device (ExoSeal) until haemostasis</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 2 days</time_frame>
    <description>Insignificant bleeding seen on the bandage or small continuous oozing is considered haemostasis. Continuous oozing will be counted as a Bleeding Academic Research Consortium (BARC) type 1 bleeding event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device failure</measure>
    <time_frame>30 minutes</time_frame>
    <description>Combined endpoint of any mechanic failure, deployment failure and/or immediate profuse bleeding needing prolonged manual compression. Individual endpoints will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vasovagal reaction until 5 minutes after end of closure procedure</measure>
    <time_frame>30 minuts</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) Scripted language will be used when discussing pain scores with the patient. Pain and discomfort score will be assessed just before and immediately after the closure procedure and reported. The delta-value will be reported and compared. The patient will be given predefined standardized instructions on how to rate and that only pain and discomfort related to the closure procedure should be assessed</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 mobilized. Patients treated for ST-elevation myocardial infarction are assessed separately</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 5x5 cm measured by ruler in the catheterization laboratory and at discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleedings according to the BARC definitions</measure>
    <time_frame>30 days</time_frame>
    <description>Access site related and non-access site related</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major bleeding and/or bleeding necessitating blood transfusion</measure>
    <time_frame>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">818</enrollment>
  <condition>Coronary Disease</condition>
  <arm_group>
    <arm_group_label>Exoseal closure device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Closure device for femoral artery access closure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Angio-Seal closure device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Closure device for femoral artery access closure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Exoseal closure device</intervention_name>
    <description>Closure device for femoral artery access closure</description>
    <arm_group_label>Exoseal closure device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Angioseal closure device</intervention_name>
    <description>Closure device for femoral artery access closure</description>
    <arm_group_label>Angio-Seal closure device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Should be able to provide valid informed signed consent&#xD;
&#xD;
          -  PCI procedure including treatment by balloon and/or stent&#xD;
&#xD;
          -  PCI indicated by silent ischemia, stable angina pectoris, non-ST elevation myocardial&#xD;
             infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Only coronary angiography&#xD;
&#xD;
          -  Multiple punctures&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Groin haematoma before the closure procedure&#xD;
&#xD;
          -  Sheath size &gt; 7 French&#xD;
&#xD;
          -  Known pseudoaneurysm or arteriovenous (AV)-fistula in the ipsilateral groin&#xD;
&#xD;
          -  Prior arterial surgery in abdomen and/or lower extremities&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Life expectancy less than one year&#xD;
&#xD;
          -  The patient is a female of childbearing potential with possible pregnancy or a&#xD;
             positive pregnancy test within 7 days before the index procedure or is lactating&#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 on same site &lt; 30 days&#xD;
&#xD;
          -  Peripheral artery disease patients can be included at operator´s discretion except if&#xD;
             heavy calcification is present at the access site which at the operator's discretion&#xD;
             precludes insertion of the VCD&#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, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Arhus University Hospital Skejby</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>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>June 6, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>May 31, 2017</last_update_submitted>
  <last_update_submitted_qc>May 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2017</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>PCI</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/NCT02234830
org study id: 1-10-72-68-12
nct id: NCT02234830
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence
      of adverse access site related events at 30 days.
Prospective, randomized (1:1) controlled, single blind, single center study in 2000
      percutaneous coronary intervention (PCI) patients comparing the ExoSeal VCD (test device) to
      the AngioSeal VCD (standard comparator). In-hospital and 30 days safety and efficacy
      endpoints and 6 months safety endpoints will be reported.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence at 30 days of the composite endpoint of access site related major adverse vascular events (MAVE)
time frame: 30 days
description: This includes: major bleeding and/or bleeding necessitating blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery and/or possible related vascular surgery, infection needing antibiotics.
measure: Time to haemostasis from removing the sheath (AngioSeal) or inserting the device (ExoSeal) until haemostasis
time frame: participants will be followed for the duration of hospital stay, an expected average of 2 days
description: Insignificant bleeding seen on the bandage or small continuous oozing is considered haemostasis. Continuous oozing will be counted as a Bleeding Academic Research Consortium (BARC) type 1 bleeding event
measure: Device failure
time frame: 30 minutes
description: Combined endpoint of any mechanic failure, deployment failure and/or immediate profuse bleeding needing prolonged manual compression. Individual endpoints will be reported.
measure: Vasovagal reaction until 5 minutes after end of closure procedure
time frame: 30 minuts
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) Scripted language will be used when discussing pain scores with the patient. Pain and discomfort score will be assessed just before and immediately after the closure procedure and reported. The delta-value will be reported and compared. The patient will be given predefined standardized instructions on how to rate and that only pain and discomfort related to the closure procedure should be assessed
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 mobilized. Patients treated for ST-elevation myocardial infarction are assessed separately
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 5x5 cm measured by ruler in the catheterization laboratory and at discharge
measure: Bleedings according to the BARC definitions
time frame: 30 days
description: Access site related and non-access site related
measure: Major bleeding and/or bleeding necessitating blood transfusion
time frame: 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: Exoseal closure device
arm group type: Experimental
description: Closure device for femoral artery access closure
arm group label: Angio-Seal closure device
arm group type: Active Comparator
description: Closure device for femoral artery access closure
intervention type: Device
intervention name: Exoseal closure device
description: Closure device for femoral artery access closure
arm group label: Exoseal closure device
intervention type: Device
intervention name: Angioseal closure device
description: Closure device for femoral artery access closure
arm group label: Angio-Seal closure device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evald H Christiansen, MD, PhD
role: Principal Investigator
affiliation: Arhus University Hospital Skejby
facility: 
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