<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/NCT01663818</url>
  </required_header>
  <id_info>
    <org_study_id>TD 0009</org_study_id>
    <nct_id>NCT01663818</nct_id>
  </id_info>
  <brief_title>Tack Optimized Balloon Angioplasty (TOBA) Study</brief_title>
  <acronym>TOBA</acronym>
  <official_title>Tack Optimized Balloon Angioplasty (TOBA) Study for Femoropopliteal Arteries Using the Tack-IT Endovascular Stapler</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Clinical &amp; Medical Affairs Global</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Clinical &amp; Medical Affairs Global</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multi-center, post-CE Mark study designed to evaluate the performance of the Intact&#xD;
      Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.;&#xD;
      post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty&#xD;
      (PTA) of superficial femoral or popliteal artery(ies).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intact Vascular intends to conduct a prospective, single arm, multi-center, post-CE Mark&#xD;
      study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular&#xD;
      Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from&#xD;
      percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal&#xD;
      artery(ies).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Safety</measure>
    <time_frame>30 days</time_frame>
    <description>Composite of new-onset major device-related adverse events.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Peripheral Vascular Disease</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with Tack-IT Endovascular Staple</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tack-It Endovascular Stapler</intervention_name>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rutherford clinical category 2, 3 or 4&#xD;
&#xD;
          -  ABI less than or equal to 0.90&#xD;
&#xD;
          -  Reference vessel diameter is between 2.5mm and 5.5mm&#xD;
&#xD;
          -  Target lesion has stenosis greater than or equal to 70% or is occluded&#xD;
&#xD;
          -  Target lesion is less than or equal to 10cm in length&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously implanted stent in the ipsilateral superficial femoral or popliteal artery&#xD;
&#xD;
          -  Target treatment area is severly calcified (e.g. circumferential calcification or&#xD;
             calcium plaque visible on plain fluoroscopy that extends far more than 5.0cm&#xD;
             continuously)&#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>Marc Bosiers, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Blasius Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dierk Scheinert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Park Hospital, Leipzig</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Patrick Peeters, MD</name>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>April 2, 2021</last_update_submitted>
  <last_update_submitted_qc>April 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Arterial 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/NCT01663818
org study id: TD 0009
nct id: NCT01663818
lead sponsor: 
has dmc: Yes
A multi-center, post-CE Mark study designed to evaluate the performance of the Intact
      Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.;
      post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty
      (PTA) of superficial femoral or popliteal artery(ies).
Intact Vascular intends to conduct a prospective, single arm, multi-center, post-CE Mark
      study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular
      Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from
      percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal
      artery(ies).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety
time frame: 30 days
description: Composite of new-onset major device-related adverse events.
arm group label: Treatment group
arm group type: Experimental
description: Treatment with Tack-IT Endovascular Staple
intervention type: Device
intervention name: Tack-It Endovascular Stapler
arm group label: Treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Bosiers, MD
role: Principal Investigator
affiliation: St. Blasius Hospital
last name: Dierk Scheinert, MD
role: Principal Investigator
affiliation: Park Hospital, Leipzig
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Vascular Diseases
mesh term: Peripheral Vascular Diseases
mesh term: Peripheral Arterial Disease