<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/NCT03013088</url>
  </required_header>
  <id_info>
    <org_study_id>CP-PER-2015-01</org_study_id>
    <nct_id>NCT03013088</nct_id>
  </id_info>
  <brief_title>Soundbite Crossing System Peripheral First in Man</brief_title>
  <official_title>A First in Man Study to Assess the Soundbite Crossing System When Used to Cross Infrainguinal Chronic Total Occlusions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SoundBite Medical Solutions, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SoundBite Medical Solutions, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a clinical study aimed at demonstrating the safety and product performance of the&#xD;
      SoundBite Crossing System. The study shall demonstrate that the SoundBite Crossing System can&#xD;
      facilitate passage of a standard guidewire through a Chronic Total Occlusion (CTO) located in&#xD;
      the lower extremity arteries without major adverse events related to SoundBite device&#xD;
      utilization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, multi-center, single-arm, two-phase clinical study. This study will be conducted&#xD;
      in two phases.&#xD;
&#xD;
      The first phase will consist of ten (10) subjects enrolled and treated using the SoundBite&#xD;
      Crossing System with 30 day follow-up. An analysis shall be performed after 10 subjects&#xD;
      undergo treatment with the SoundBite Crossing System and complete 30 day follow-up. This&#xD;
      analysis shall be utilized to provide insight into product performance and safety.&#xD;
&#xD;
      The second phase will consist of up to forty (40) subjects enrolled and treated using the&#xD;
      SoundBite Crossing System with 30 day follow-up. An analysis will be generated on this&#xD;
      subject cohort after 30 day follow-up is complete.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Device Success</measure>
    <time_frame>30 Day follow-up</time_frame>
    <description>Device Success is the primary endpoint for the study. Device Success is defined as the achievement of Technical Success with freedom from Major Adverse Events through 30 day follow-up, per Independent Physician Reviewer (IPR) adjudication.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical Success</measure>
    <time_frame>At the time of the index procedure</time_frame>
    <description>Technical Success: the ability of the SoundBite Crossing System to facilitate crossing of a target CTO lesion, defined as: The ShockWireTM being advanced by 1cm or more into proximal aspect of target CTO lesion based on angiography; AND Either the ShockWireTM or other commercially available device (e.g. guidewire) is able to cross target CTO lesion.&#xD;
Technical Success shall be assessed at the time of the index procedure after all ShockWireTM devices have been used on the target CTO lesion (if more than one ShockWireTM device was utilized to address the target CTO lesion).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <arm_group>
    <arm_group_label>CTO Crossing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>With confirmation that the target vessel is completely occluded by the target CTO lesion, the operator shall initially attempt crossing the proximal end of the target CTO lesion by advancing ShockWireTM device ≥ 1cm. The SoundBite Crossing device can be activated as needed to perform the procedure and may be used for the entire length of the lesion(s).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CTO Crossing</intervention_name>
    <description>With confirmation that the target vessel is completely occluded by the target CTO lesion, the operator shall initially attempt crossing the proximal end of the target CTO lesion by advancing ShockWireTM device ≥ 1cm. The SoundBite Crossing device can be activated as needed to perform the procedure and may be used for the entire length of the lesion(s).</description>
    <arm_group_label>CTO Crossing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Symptomatic target leg ischemia, requiring treatment of an infrainguinal artery.&#xD;
&#xD;
          2. Rutherford Category of 2-5.&#xD;
&#xD;
          3. ≥ 18 years of age.&#xD;
&#xD;
          4. Life expectancy &gt; 1 year.&#xD;
&#xD;
          5. Able and willing to provide written informed consent prior to study procedure.&#xD;
&#xD;
          6. Evidence that the target CTO lesion is a de novo or restenotic chronic total occlusion&#xD;
             in the SFA (starting at least 1cm distal to the origin of the SFA) and/or popliteal&#xD;
             artery (ending at least 1cm proximal to the popliteal trifurcation), confirmed by&#xD;
             angiography; AND/OR Evidence that the target CTO lesion is a de novo or restenotic&#xD;
             chronic total occlusion and is located below the popliteal trifurcation in the&#xD;
             anterior tibial, posterior tibial or peroneal arteries (at least 1 cm distal to the&#xD;
             vessel origin, and ending at least 1cm proximal to the dorsalis pedis or plantar&#xD;
             arteries), confirmed by angiography.&#xD;
&#xD;
          7. Target CTO lesion is 100% occluded by visual estimate.&#xD;
&#xD;
          8. Target limb has at least one patent (&lt;50% stenosis) tibio-peroneal run-off vessel to&#xD;
             the foot confirmed by baseline angiography or magnetic resonance angiography (MRA) or&#xD;
             computed tomography angiography (CTA).&#xD;
&#xD;
          9. Target CTO lesion has a cumulative lesion length of no more than 40 cm and terminates&#xD;
             at least 1 cm above the ankle or tibio-talar joint.&#xD;
&#xD;
         10. Reference vessel diameter, by visual estimate, is ≥ 4 mm for femoral-popliteal&#xD;
             arteries, or ≥ 2 mm for tibial or peroneal arteries.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of previous peripheral bypass or stent placement, affecting the target CTO&#xD;
             lesion (i.e. target CTO lesion (de novo or restenotic) must be at least 1cm proximal&#xD;
             or distal to a surgical bypass graft anastomosis or stent edge to be eligible for&#xD;
             treatment).&#xD;
&#xD;
          2. History of receiving a kidney transplant.&#xD;
&#xD;
          3. Current significant acute or chronic kidney disease with a creatinine level &gt; 220&#xD;
             micromoles/Land/or requiring dialysis.&#xD;
&#xD;
          4. Known or suspected active infection at the time of the index procedure, excluding an&#xD;
             infection of a lower extremity wound of the target limb.&#xD;
&#xD;
          5. History of an endovascular procedure or open vascular surgery on the index limb within&#xD;
             the 30 days prior to enrollment.&#xD;
&#xD;
          6. Any planned surgical or interventional procedure within 30 days after the index&#xD;
             procedure.&#xD;
&#xD;
          7. Unstable coronary artery disease or other uncontrolled comorbidity.&#xD;
&#xD;
          8. Myocardial infarction or stroke within 3 months prior to enrollment.&#xD;
&#xD;
          9. Currently pregnant or breast-feeding.&#xD;
&#xD;
         10. Participating in any study of an investigational device, medication, biologic, or&#xD;
             other agent within 30 days prior to enrollment that is either a cardiovascular study&#xD;
             or could, in the judgement of the Investigator, affect the results of this study.&#xD;
&#xD;
         11. Known significant stenosis or occlusion of inflow tract (upstream disease) not&#xD;
             successfully treated before index procedure.&#xD;
&#xD;
         12. Contraindication to antiplatelet medications, anticoagulant medication, or&#xD;
             thrombolytic therapy.&#xD;
&#xD;
         13. Current uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with&#xD;
             platelet count less than 100,000/microliter, known coagulopathy, or INR &gt;1.5.&#xD;
&#xD;
         14. Known allergy to contrast agents or medications used to perform endovascular&#xD;
             intervention that cannot be adequately pre-treated.&#xD;
&#xD;
         15. History of heparin-induced thrombocytopenia (HIT).&#xD;
&#xD;
         16. Received thrombolytic therapy within two weeks of enrollment.&#xD;
&#xD;
         17. Known psychiatric disorder which in the judgement of the Investigator could interfere&#xD;
             with provision of informed consent, completion of tests, therapy, or follow-up.&#xD;
&#xD;
         18. Clinical/angiographic complication (other than non-flow limiting dissections)&#xD;
             attributed to a currently marketed device prior to introduction of SoundBite Crossing&#xD;
             System.&#xD;
&#xD;
         19. Acute or sub-acute intraluminal thrombus within the target vessel.&#xD;
&#xD;
         20. Aneurysm (at least twice the reference vessel diameter) located in the target vessel&#xD;
             or popliteal artery.&#xD;
&#xD;
         21. Perforation, dissection or other injury of the access or target vessel requiring&#xD;
             stenting or surgical intervention.&#xD;
&#xD;
         22. Clinical/angiographic evidence of distal embolization in the target limb.&#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>Andrew Benko, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHUS - Centre Hospitalier Universitaire de Sherbrooke - Fleurimont</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHUM - Centre Hospitalier de l'Université de Montreal - Hôtel-Dieu</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2W 1T8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUS - Centre Hospitalier Universitaire de Sherbrooke - Freurimont</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>November 14, 2017</last_update_submitted>
  <last_update_submitted_qc>November 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic</keyword>
  <keyword>Occlusion</keyword>
  <keyword>CTO</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
  </condition_browse>
  <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/NCT03013088
org study id: CP-PER-2015-01
nct id: NCT03013088
lead sponsor: 
has dmc: No
This is a clinical study aimed at demonstrating the safety and product performance of the
      SoundBite Crossing System. The study shall demonstrate that the SoundBite Crossing System can
      facilitate passage of a standard guidewire through a Chronic Total Occlusion (CTO) located in
      the lower extremity arteries without major adverse events related to SoundBite device
      utilization.
Prospective, multi-center, single-arm, two-phase clinical study. This study will be conducted
      in two phases.

      The first phase will consist of ten (10) subjects enrolled and treated using the SoundBite
      Crossing System with 30 day follow-up. An analysis shall be performed after 10 subjects
      undergo treatment with the SoundBite Crossing System and complete 30 day follow-up. This
      analysis shall be utilized to provide insight into product performance and safety.

      The second phase will consist of up to forty (40) subjects enrolled and treated using the
      SoundBite Crossing System with 30 day follow-up. An analysis will be generated on this
      subject cohort after 30 day follow-up is complete.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Device Success
time frame: 30 Day follow-up
description: Device Success is the primary endpoint for the study. Device Success is defined as the achievement of Technical Success with freedom from Major Adverse Events through 30 day follow-up, per Independent Physician Reviewer (IPR) adjudication.
measure: Technical Success
time frame: At the time of the index procedure
description: Technical Success: the ability of the SoundBite Crossing System to facilitate crossing of a target CTO lesion, defined as: The ShockWireTM being advanced by 1cm or more into proximal aspect of target CTO lesion based on angiography; AND Either the ShockWireTM or other commercially available device (e.g. guidewire) is able to cross target CTO lesion.
Technical Success shall be assessed at the time of the index procedure after all ShockWireTM devices have been used on the target CTO lesion (if more than one ShockWireTM device was utilized to address the target CTO lesion).
arm group label: CTO Crossing
arm group type: Experimental
description: With confirmation that the target vessel is completely occluded by the target CTO lesion, the operator shall initially attempt crossing the proximal end of the target CTO lesion by advancing ShockWireTM device ≥ 1cm. The SoundBite Crossing device can be activated as needed to perform the procedure and may be used for the entire length of the lesion(s).
intervention type: Device
intervention name: CTO Crossing
description: With confirmation that the target vessel is completely occluded by the target CTO lesion, the operator shall initially attempt crossing the proximal end of the target CTO lesion by advancing ShockWireTM device ≥ 1cm. The SoundBite Crossing device can be activated as needed to perform the procedure and may be used for the entire length of the lesion(s).
arm group label: CTO Crossing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Benko, MD
role: Principal Investigator
affiliation: CHUS - Centre Hospitalier Universitaire de Sherbrooke - Fleurimont
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
sharing ipd: No