<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/NCT02235675</url>
  </required_header>
  <id_info>
    <org_study_id>TD 0109</org_study_id>
    <nct_id>NCT02235675</nct_id>
  </id_info>
  <brief_title>Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study</brief_title>
  <acronym>TOBABTK</acronym>
  <official_title>Prospective, Multicenter Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study for Infrapopliteal Arteries Using the Tack-It Endovascular System™</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>
      Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating&#xD;
      tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from&#xD;
      1.5mm to 4.5mm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This first in man (FIM) study is to collect data in support of the safety and performance of&#xD;
      the Intact Vascular Tack-It Endovascular System™ for tissue apposition to optimize balloon&#xD;
      angioplasty.&#xD;
&#xD;
      Study primary endpoints:&#xD;
&#xD;
      Safety: Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD),&#xD;
      assessed at 1 month. Endpoint includes any of the following:&#xD;
&#xD;
        -  Major amputation - amputation above the ankle&#xD;
&#xD;
        -  Re-intervention (surgical or endovascular) in the target limb&#xD;
&#xD;
        -  Procedure-related death - any death within 1 month of the index procedure or any MALE&#xD;
&#xD;
      Device Success: The achievement of successful delivery and deployment of the study device(s)&#xD;
      at the intended target site(s) and successful withdrawal of the delivery catheter.&#xD;
&#xD;
      Technical Success: Device success (defined above) and the ability of the Tack to resolve&#xD;
      post-PTA dissection, demonstrating angiographic patency at the conclusion of the procedure.&#xD;
&#xD;
      Clinical Success: Ability of the Tack to resolve post-PTA dissection and achieve patency at&#xD;
      the conclusion of the procedure, without procedure related complications within 48 hours&#xD;
      after the index procedure or at hospital discharge, whichever is sooner.&#xD;
&#xD;
      Study secondary endpoints:&#xD;
&#xD;
      The following events will be assessed at 3, 6 and 12 months:&#xD;
&#xD;
        -  All-cause mortality&#xD;
&#xD;
        -  Amputation of the limb (above the ankle)&#xD;
&#xD;
        -  Amputation free survival&#xD;
&#xD;
        -  Clinically driven target vessel revascularization (TVR)&#xD;
&#xD;
        -  Clinically driven target lesion revascularization (TLR)&#xD;
&#xD;
        -  Changes in Rutherford Clinical Category from baseline&#xD;
&#xD;
      The following parameters will be assessed at 1, 3, 6 and 12 months:&#xD;
&#xD;
        -  Maintenance of luminal patency of the target lesion by TBI (≤0.15 decrease) as compared&#xD;
           to the baseline TBI obtained prior to discharge&#xD;
&#xD;
        -  Doppler Exam (presence of signal)&#xD;
&#xD;
      Study observational endpoint:&#xD;
&#xD;
      The following parameter will be assessed at 6 months (Per local Standard of Care):&#xD;
&#xD;
      • Angiographic percent diameter stenosis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 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 Endpoints</measure>
    <time_frame>30 Days</time_frame>
    <description>Safety: Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD), assessed at 1 month. Endpoint includes any of the following:&#xD;
Major amputation - amputation above the ankle&#xD;
Re-intervention (surgical or endovascular) in the target limb&#xD;
Procedure-related death - any death within 1 month of the index procedure or any MALE</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Endpoints</measure>
    <time_frame>1, 3, 6 and 12 Months</time_frame>
    <description>The composite of following events will be assessed at 3, 6 and 12 months or as noted:&#xD;
All-cause mortality&#xD;
Amputation of the limb (above the ankle)&#xD;
Amputation free survival&#xD;
Clinically driven target vessel revascularization (TVR)&#xD;
Clinically driven target lesion revascularization (TLR)&#xD;
Changes in Rutherford Clinical Category from baseline&#xD;
Maintenance of luminal patency of the target lesion by TBI (≤0.15 decrease) as compared to the baseline TBI obtained prior to discharge at 1,3,6 and 12 months.&#xD;
Doppler Exam (presence of signal at 1,3,6 and 12 months)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Observational Endpoint</measure>
    <time_frame>6 Months</time_frame>
    <description>The following parameter will be assessed at 6 months (Per local Standard of Care):&#xD;
• Angiographic percent diameter stenosis</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Critical Limb Ischemia</condition>
  <condition>Peripheral Artery Disease</condition>
  <arm_group>
    <arm_group_label>Tack-It</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implant of the Intact Vascular Tack-It Endovascular System to repair post angioplasty dissections.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tack-It Endovascular System</intervention_name>
    <description>Repair of post-PTA dissections using the Intact Vascular Tack-It implant.</description>
    <arm_group_label>Tack-It</arm_group_label>
    <other_name>Tack-It Dissection Repair</other_name>
    <other_name>Intact Vascular Tack-It</other_name>
    <other_name>Tack-It</other_name>
    <other_name>Tack</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of subject is &gt;18&#xD;
&#xD;
          -  Subject or subject's legal representative has been informed of the nature of the&#xD;
             study, agrees to participate and has signed the consent form&#xD;
&#xD;
          -  Subject has critical limb ischemia (CLI)&#xD;
&#xD;
          -  Subject has Rutherford Clinical Category 4-5. (hemodynamic reference)&#xD;
&#xD;
          -  Reference vessel diameter below the knee (BTK) is between 1.5mm and 4.5mm (inclusive).&#xD;
&#xD;
          -  De-novo target lesion(s) has stenosis &gt;70%.&#xD;
&#xD;
          -  Must be able to perform PTA. The PTA must result in a dissection Type A - F at some&#xD;
             location along the treatment site.&#xD;
&#xD;
          -  Any vessel intervened on must have distal reconstitution above the ankle.&#xD;
&#xD;
          -  Inflow Iliac, SFA and Popliteal lesions can be treated during the same procedure using&#xD;
             standard angioplasty and/or an approved device. These inflow lesions must be treated&#xD;
             first, prior to consideration of treatment of BTK lesions. The patient can be enrolled&#xD;
             if the inflow lesions are treated with good angiographic results (must have &lt;30%&#xD;
             residual stenosis and no evidence of embolization).&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  The subject has a lesion on the plantar surface of the heel or over the Achilles&#xD;
             tendon or has exposed calcaneus.&#xD;
&#xD;
          -  The subject has extensive forefoot gangrene / ischemic ulcer that cannot be resolved&#xD;
             with standard metatarsal amputation.&#xD;
&#xD;
          -  Previous treatment failure of inflow arteries (Iliac, SFA and Popliteal)&#xD;
&#xD;
          -  Subject with below knee bypass.&#xD;
&#xD;
          -  Subject has significant stenosis or occlusion of inflow vessels tract (proximal&#xD;
             disease) not successfully treated (&gt;30% residual stenosis and/or complication of the&#xD;
             procedure) prior to BTK angioplasty and patient enrollment.&#xD;
&#xD;
          -  Subject is permanently wheel-chair bound or bedridden.&#xD;
&#xD;
          -  Subject has an allergy to contrast medium that cannot be pretreated.&#xD;
&#xD;
          -  Episode of acute limb ischemia within the previous 30 days.&#xD;
&#xD;
          -  Subject is undergoing atherectomy in the target limb or cryoplasty or stenting of BTK&#xD;
             treatment site.&#xD;
&#xD;
          -  Subject has a systemic infection with positive blood cultures/bacteremia within one&#xD;
             week.&#xD;
&#xD;
          -  Subject has undrained pus or spreading wet gangrene in the foot that is not controlled&#xD;
             at the time of revascularization procedure.&#xD;
&#xD;
          -  Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is&#xD;
             contraindicated.&#xD;
&#xD;
          -  Myocardial infarction within 30 days prior to enrollment.&#xD;
&#xD;
          -  History of stroke within 180 days prior to enrollment.&#xD;
&#xD;
          -  Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of&#xD;
             &gt;2.5 mg/dL or &gt;220 umol/L).&#xD;
&#xD;
          -  Subject has a known hypersensitivity or contraindication to nitinol.&#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>Marianne Brodmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MEDIZINISCHE UNIVERSITAT GRAZ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medizinische Universitat Graz</name>
      <address>
        <city>Graz</city>
        <zip>A-8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</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>
  <keyword>Angioplasty</keyword>
  <keyword>Peripheral Artery Disease</keyword>
  <keyword>Critical Limb Ischemia</keyword>
  <keyword>CLI</keyword>
  <keyword>PAD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Chronic Limb-Threatening Ischemia</mesh_term>
    <mesh_term>Ischemia</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/NCT02235675
org study id: TD 0109
nct id: NCT02235675
lead sponsor: 
has dmc: Yes
Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating
      tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from
      1.5mm to 4.5mm.
This first in man (FIM) study is to collect data in support of the safety and performance of
      the Intact Vascular Tack-It Endovascular System™ for tissue apposition to optimize balloon
      angioplasty.

      Study primary endpoints:

      Safety: Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD),
      assessed at 1 month. Endpoint includes any of the following:

        -  Major amputation - amputation above the ankle

        -  Re-intervention (surgical or endovascular) in the target limb

        -  Procedure-related death - any death within 1 month of the index procedure or any MALE

      Device Success: The achievement of successful delivery and deployment of the study device(s)
      at the intended target site(s) and successful withdrawal of the delivery catheter.

      Technical Success: Device success (defined above) and the ability of the Tack to resolve
      post-PTA dissection, demonstrating angiographic patency at the conclusion of the procedure.

      Clinical Success: Ability of the Tack to resolve post-PTA dissection and achieve patency at
      the conclusion of the procedure, without procedure related complications within 48 hours
      after the index procedure or at hospital discharge, whichever is sooner.

      Study secondary endpoints:

      The following events will be assessed at 3, 6 and 12 months:

        -  All-cause mortality

        -  Amputation of the limb (above the ankle)

        -  Amputation free survival

        -  Clinically driven target vessel revascularization (TVR)

        -  Clinically driven target lesion revascularization (TLR)

        -  Changes in Rutherford Clinical Category from baseline

      The following parameters will be assessed at 1, 3, 6 and 12 months:

        -  Maintenance of luminal patency of the target lesion by TBI (≤0.15 decrease) as compared
           to the baseline TBI obtained prior to discharge

        -  Doppler Exam (presence of signal)

      Study observational endpoint:

      The following parameter will be assessed at 6 months (Per local Standard of Care):

      • Angiographic percent diameter stenosis
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Endpoints
time frame: 30 Days
description: Safety: Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD), assessed at 1 month. Endpoint includes any of the following:
Major amputation - amputation above the ankle
Re-intervention (surgical or endovascular) in the target limb
Procedure-related death - any death within 1 month of the index procedure or any MALE
measure: Secondary Endpoints
time frame: 1, 3, 6 and 12 Months
description: The composite of following events will be assessed at 3, 6 and 12 months or as noted:
All-cause mortality
Amputation of the limb (above the ankle)
Amputation free survival
Clinically driven target vessel revascularization (TVR)
Clinically driven target lesion revascularization (TLR)
Changes in Rutherford Clinical Category from baseline
Maintenance of luminal patency of the target lesion by TBI (≤0.15 decrease) as compared to the baseline TBI obtained prior to discharge at 1,3,6 and 12 months.
Doppler Exam (presence of signal at 1,3,6 and 12 months)
measure: Observational Endpoint
time frame: 6 Months
description: The following parameter will be assessed at 6 months (Per local Standard of Care):
• Angiographic percent diameter stenosis
arm group label: Tack-It
arm group type: Experimental
description: Implant of the Intact Vascular Tack-It Endovascular System to repair post angioplasty dissections.
intervention type: Device
intervention name: Tack-It Endovascular System
description: Repair of post-PTA dissections using the Intact Vascular Tack-It implant.
arm group label: Tack-It
other name: Tack-It Dissection Repair
other name: Intact Vascular Tack-It
other name: Tack-It
other name: Tack
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marianne Brodmann, MD
role: Principal Investigator
affiliation: MEDIZINISCHE UNIVERSITAT GRAZ
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia