<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/NCT02241642</url>
  </required_header>
  <id_info>
    <org_study_id>P190-00</org_study_id>
    <secondary_id>CIV-13-11-011700</secondary_id>
    <nct_id>NCT02241642</nct_id>
  </id_info>
  <brief_title>Safety and Performance Study of Large Hole Vascular Closure Device</brief_title>
  <acronym>FRONTIER-II</acronym>
  <official_title>Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vivasure Medical Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vivasure Medical Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this Clinical Investigation is to validate that the clinical use of the&#xD;
      VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm&#xD;
      its performance to percutaneously close femoral arterial puncture sites in the range of 18-24&#xD;
      F, post endovascular procedures.&#xD;
&#xD;
      This is a non-inferiority study based on safety. Safety will be assessed by incidence and&#xD;
      severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3&#xD;
      months from implantation is no worse than those associated with cut-down and sutured close.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a prospective, multi-centred, non-randomized study to investigate the&#xD;
      safety and performance of the VIVASURE CLOSURE DEVICE™. The study shall not be blinded prior&#xD;
      to, during or post the procedure. All patients undergoing a procedure requiring an&#xD;
      arteriotomy in the range of 18 to 24 F, via the common femoral artery will be screened&#xD;
      against the inclusion/exclusion criteria. If the patient meets the requirements of the&#xD;
      clinical investigation, they shall be invited to participate, provide informed consent and&#xD;
      shall subsequently be assigned a subject number.&#xD;
&#xD;
      All subjects shall have an immediately post procedure, 24 hour, 1, 3 and 12 month follow-up&#xD;
      assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring&#xD;
      Committee.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2013</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Endpoint</measure>
    <time_frame>3 months</time_frame>
    <description>Incidence and severity of major complication rates (as defined by VARC-2) directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, is no worse than those associated with cut-down and sutured close</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Endpoint</measure>
    <time_frame>3 Months</time_frame>
    <description>Incidence of minor complications (as defined by VARC-2) directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Performance</measure>
    <time_frame>Immediate</time_frame>
    <description>Technical success rate for the VIVASURE CLOSURE DEVICE™</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Percutaneous Common Femoral Artery Arteriotomy Closure</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VIVASURE CLOSURE DEVICE™</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VIVASURE CLOSURE DEVICE™</intervention_name>
    <description>Large hole vascular closure device</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Each patient, or his or her guardian or legal representative, is willing to give&#xD;
             informed consent&#xD;
&#xD;
          -  Clinically indicated for an endovascular procedure involving access through the&#xD;
             femoral artery, with an access puncture of 18 - 24 French (F)&#xD;
&#xD;
          -  Females who are not pregnant or lactating, and not planning to become pregnant in ≤ 12&#xD;
             months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe acute non-cardiac systemic disease or terminal illness with a life expectancy&#xD;
             of less than one year&#xD;
&#xD;
          -  Evidence of systemic bacterial or cutaneous infection&#xD;
&#xD;
          -  Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE&#xD;
             (vancomycin-resistant Enterococci) colonisation&#xD;
&#xD;
          -  Arterial access other than the common femoral artery&#xD;
&#xD;
          -  Patients suffering with definitive or potential coagulopathy or platelet count less&#xD;
             than 100,000/μl&#xD;
&#xD;
          -  Patient with a haematocrit of less than 32 %&#xD;
&#xD;
          -  A measured activated clotting time (ACT) of greater than 350 seconds immediately prior&#xD;
             to sheath removal&#xD;
&#xD;
          -  If patients are expected to be continuously treated with anticoagulation therapy&#xD;
             post-procedure such that their ACT reading is expected to be elevated above 350&#xD;
             seconds for more than 24 hours after the procedure&#xD;
&#xD;
          -  Evidence of arterial diameter stenosis greater than 20 % within 20 mm of the&#xD;
             arteriotomy&#xD;
&#xD;
          -  Circumferential calcification within 20 mm of the arteriotomy&#xD;
&#xD;
          -  Use of systemic thrombolytic agents within 24 hours prior to or during the&#xD;
             catheterisation procedure which cause the concentration of fibrinogen to be less than&#xD;
             100 mg/dl&#xD;
&#xD;
          -  Patients in which the arteriotomy is less than 18 F or greater than 24 F&#xD;
&#xD;
          -  Known allergy to any of the materials used in the device&#xD;
&#xD;
          -  Currently enrolled in any other investigational clinical study, whereby the primary&#xD;
             endpoint has not yet been achieved&#xD;
&#xD;
          -  Patients judged unsuitable for surgical repair of the access site&#xD;
&#xD;
          -  If puncture site is via a vascular graft&#xD;
&#xD;
          -  If there is any indication that the puncture has been made in the profunda femoris or&#xD;
             located less than 10 mm above the profunda femoris&#xD;
&#xD;
          -  Patients with a common femoral artery lumen diameter of less than 7 mm&#xD;
&#xD;
          -  Patients that have a lower extremity amputation from the ipsilateral or contralateral&#xD;
             limb&#xD;
&#xD;
          -  Patients that have undergone a percutaneous procedure using a non-absorbable vascular&#xD;
             closure device (excluding suture mediated) for haemostasis in the ipsilateral leg&#xD;
&#xD;
          -  Patients that have undergone a percutaneous procedure greater than 8 F in the&#xD;
             ipsilateral leg, within the previous 90 days&#xD;
&#xD;
          -  Patients that have undergone a percutaneous procedure of 8 F or less using an&#xD;
             absorbable intravascular closure device for haemostasis, in the ipsilateral leg,&#xD;
             within the previous 90 days&#xD;
&#xD;
          -  Patients that have undergone a percutaneous procedure of 8 F or less using a suture&#xD;
             mediated closure device for haemostasis, in the ipsilateral leg, within the previous&#xD;
             30 days&#xD;
&#xD;
          -  Patients that have undergone a percutaneous procedure of 8 F or less using&#xD;
             manual/mechanical pressure for haemostasis in the ipsilateral leg, within the previous&#xD;
             30 days&#xD;
&#xD;
          -  Patients with an acute haematoma of any size, arteriovenous fistula or Pseudoaneurysm&#xD;
             at the access site&#xD;
&#xD;
          -  Significant blood loss/transfusion during interventional procedure or within 20 days&#xD;
             of procedure requiring transfusion of greater than 4 units of blood&#xD;
&#xD;
          -  Angiographic evidence of arterial laceration, dissection or stenosis within the&#xD;
             external iliac or femoral artery before the use of the VCD&#xD;
&#xD;
          -  Severe claudication, stenosis of the iliac artery &gt; 50% or previous bypass&#xD;
             surgery/stent placement in the region of the vascular access&#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>Prof. Dr. med Giovanni Torsello, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St Fraziskus Hospital, Muenster, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Antwerp (UZA)</name>
      <address>
        <city>Edegem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Charité - Universitätsmedizin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Klinikum im Friedrichshain</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Bonn</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Franziskus Hospital</name>
      <address>
        <city>Muenster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blackrock Clinic</name>
      <address>
        <city>Blackrock</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's Hospital</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>January 30, 2018</last_update_submitted>
  <last_update_submitted_qc>January 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Percutaneous vascular closure device</keyword>
  <keyword>vascular closure device</keyword>
  <keyword>Large hole closure device</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02241642
org study id: P190-00
secondary id: CIV-13-11-011700
nct id: NCT02241642
lead sponsor: 
has dmc: Yes
The purpose of this Clinical Investigation is to validate that the clinical use of the
      VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm
      its performance to percutaneously close femoral arterial puncture sites in the range of 18-24
      F, post endovascular procedures.

      This is a non-inferiority study based on safety. Safety will be assessed by incidence and
      severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3
      months from implantation is no worse than those associated with cut-down and sutured close.
This study will be a prospective, multi-centred, non-randomized study to investigate the
      safety and performance of the VIVASURE CLOSURE DEVICE™. The study shall not be blinded prior
      to, during or post the procedure. All patients undergoing a procedure requiring an
      arteriotomy in the range of 18 to 24 F, via the common femoral artery will be screened
      against the inclusion/exclusion criteria. If the patient meets the requirements of the
      clinical investigation, they shall be invited to participate, provide informed consent and
      shall subsequently be assigned a subject number.

      All subjects shall have an immediately post procedure, 24 hour, 1, 3 and 12 month follow-up
      assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring
      Committee.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Endpoint
time frame: 3 months
description: Incidence and severity of major complication rates (as defined by VARC-2) directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, is no worse than those associated with cut-down and sutured close
measure: Secondary Endpoint
time frame: 3 Months
description: Incidence of minor complications (as defined by VARC-2) directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation.
measure: Performance
time frame: Immediate
description: Technical success rate for the VIVASURE CLOSURE DEVICE™
arm group label: Treatment
arm group type: Experimental
description: VIVASURE CLOSURE DEVICE™
intervention type: Device
intervention name: VIVASURE CLOSURE DEVICE™
description: Large hole vascular closure device
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Prof. Dr. med Giovanni Torsello, MD
role: Principal Investigator
affiliation: St Fraziskus Hospital, Muenster, Germany
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Germany
country: Ireland
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No