<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/NCT03266835</url>
  </required_header>
  <id_info>
    <org_study_id>NAP-PER-2017-01</org_study_id>
    <nct_id>NCT03266835</nct_id>
  </id_info>
  <brief_title>SoundBite™ Crossing System Pivotal Peripheral CTO Crossing Study</brief_title>
  <acronym>PROSPECTOR</acronym>
  <official_title>A Multinational, Single-Arm Pivotal Study to Assess the Performance Rate Of SoundBite™ Active Wire for PEripheral Chronic Total Occlusion Recanalization (PROSPECTOR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SoundBite Medical Solutions, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ethica Clinical Research Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Prairie Vascular Research Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>SoundBite Medical Solutions, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is aimed at demonstrating the efficacy and safety of the SoundBite™ Crossing&#xD;
      System-Peripheral. The study is intended to demonstrate that the SoundBite™ Crossing System&#xD;
      can facilitate the passage of either devices intended to treat a chronic total occlusion&#xD;
      (CTO) or additional crossing devices through an infrainguinal CTO into the true lumen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multinational, single-arm, pivotal trial assessing the efficacy and safety of the&#xD;
      SoundBite™ Crossing System - Peripheral. The enrollment will consist of up to 100 patients&#xD;
      meeting the inclusion/exclusion criteria in order to obtain 90 evaluable patients for&#xD;
      efficacy and safety analysis. The primary endpoints will be compared to literature-based&#xD;
      performance goals to establish study success.&#xD;
&#xD;
      Objective Performance Goals (OPG) have been obtained from a literature based review. Reports&#xD;
      published in the past 10 years were reviewed for both safety and effectiveness in crossing&#xD;
      infrainguinal CTO. The studies reviewed generally have one primary composite safety endpoint&#xD;
      and one primary efficacy endpoint. Some studies have performed formal hypothesis testing&#xD;
      versus a pre-specified performance goal for one or both endpoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2017</start_date>
  <completion_date type="Actual">January 18, 2019</completion_date>
  <primary_completion_date type="Actual">January 18, 2019</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>Technical Device Success</measure>
    <time_frame>Day 1</time_frame>
    <description>Ability to facilitate treatment of the target lesion by allowing additional crossing and/or treatment devices to cross the CTO</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Freedom from SoundBite™ Crossing System related MAEs at 30 days post procedure</measure>
    <time_frame>up to Day 30</time_frame>
    <description>MAEs defined as:&#xD;
Cardiovascular related deaths&#xD;
Unplanned, index limb amputation&#xD;
Dissection of grade C or greater that require an intervention to resolve&#xD;
Symptomatic distal embolization, defined as clinical signs or symptoms of distal emboli detected in the treated limb distal to the treated lesion after the index procedure or noted angiographically after the index procedure, and requiring mechanical or pharmacologic means to improve flow</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedural success</measure>
    <time_frame>Day 1</time_frame>
    <description>Achievement of Technical Success together with post-procedural patency. Post-procedural patency is defined as less then or equal to 50% residual percent diameter stenosis assessed by visual estimate at the end of revascularization procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Success</measure>
    <time_frame>Up to Day 30</time_frame>
    <description>Achievement of Procedural Success as well as freedom from SoundBite™ Crossing System related MAEs at 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penetration ≥ 0.5 cm</measure>
    <time_frame>Day 1</time_frame>
    <description>Ability of the SoundBite™ Crossing System to penetrate ≥ 0.5 cm of any segment of the CTO</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fully traverse</measure>
    <time_frame>Day 1</time_frame>
    <description>Ability of the SoundBite™ Crossing System to fully traverse the CTO with entry into the distal true lumen without the need for additional guidewires and/or re-entry devices</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from any SoundBite™ Crossing System related Adverse Events</measure>
    <time_frame>Up to Day 30</time_frame>
    <description>Freedom from any SoundBite™ Crossing System related Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Chronic Total Occlusion of Arteries of the Extremities</condition>
  <arm_group>
    <arm_group_label>SoundBite™ Crossing System - Peripheral</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a multinational, single-arm, pivotal trial assessing the efficacy and safety of the SoundBite™ Crossing System with subjects diagnosed with de novo infrainguinal arterial chronic total occlusion(s).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SoundBite™ Crossing System - Peripheral</intervention_name>
    <description>SoundBite™ Crossing System consisting of the SoundBite™ Console and SoundBite™ Active Wire 18. The Investigator may use the SoundBite™ Active Wire during the procedure to cross the proximal aspect and/or to cross multiple lesions.</description>
    <arm_group_label>SoundBite™ Crossing System - Peripheral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General Inclusion Criteria:&#xD;
&#xD;
          1. Has symptomatic chronic limb ischemia, requiring treatment of an in:frainguinal artery&#xD;
&#xD;
          2. Has Rutherford Clinical Category of 2-5&#xD;
&#xD;
          3. Is ≥ 18 years old&#xD;
&#xD;
          4. Has life expectancy &gt; 1 year&#xD;
&#xD;
          5. Is able and willing to provide written informed consent prior to study procedure&#xD;
&#xD;
        Angiographic Inclusion Criteria:&#xD;
&#xD;
        Unless otherwise specified, the Investigator performing the procedure bases angiographic&#xD;
        inclusion on visual determination of qualification imaging taken at time of procedure.&#xD;
&#xD;
        Subject must meet ALL the following angiographic inclusion criteria:&#xD;
&#xD;
          1. Has evidence of a clinically significant de novo CTO located in a peripheral vessel&#xD;
             below the infrainguinal ligament confirmed by angiography at time of procedure.&#xD;
&#xD;
          2. Notwithstanding criteria 1, multilevel CTOs are included as long as the total length&#xD;
             from the beginning of the most proximal total occlusion to the end of the most distal&#xD;
             total occlusion is less than 40 cm.&#xD;
&#xD;
          3. 100% stenosis by visual estimate of angiography at time of procedure.&#xD;
&#xD;
          4. Has target limb with at least one patent (&lt;50% stenosis) run-off vessel confirmed by&#xD;
             angiography or magnetic resonance angiography at time of procedure.&#xD;
&#xD;
        General Exclusion Criteria:&#xD;
&#xD;
          1. Has had a previous peripheral bypass that includes the target vessel.&#xD;
&#xD;
          2. Has had a previous intervention on the target CTO (e.g., angioplasty, stent&#xD;
             placement), including previous attempt at time of index procedure.&#xD;
&#xD;
          3. History of any vascular procedure on the index limb within the last 30 days requiring&#xD;
             clinically driven re-intervention.&#xD;
&#xD;
          4. Has an active infection in the target limb.&#xD;
&#xD;
          5. Subject has any planned major surgical or interventional procedure within 30 days&#xD;
             after the study procedure.&#xD;
&#xD;
          6. Has received a kidney transplant.&#xD;
&#xD;
          7. Glomerular Filtration Rate (GFR) of less than 40.&#xD;
&#xD;
          8. Unstable coronary artery disease or other uncontrolled comorbidity.&#xD;
&#xD;
          9. Myocardial infarction or stroke within 2 months prior to baseline evaluation.&#xD;
&#xD;
         10. Subject has positive pregnancy test result in women of child bearing potential or is&#xD;
             breast-feeding.&#xD;
&#xD;
         11. Participation in any study of an investigational device, medication, biologic, or&#xD;
             other agent during study or within 30 days prior to enrollment that is either a&#xD;
             cardiovascular study or could, in the judgment of the investigator, affect the results&#xD;
             of this study.&#xD;
&#xD;
         12. Subject in whom antiplatelet, anticoagulant therapy is contraindicated&#xD;
&#xD;
         13. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet&#xD;
             count less than 100,000/ml or known coagulopathy.&#xD;
&#xD;
         14. Known, untreated allergy to contrast agents or medications used during or subsequent&#xD;
             to endovascular intervention. Patients with aspirin allergy that have been&#xD;
             desensitized are not excluded.&#xD;
&#xD;
         15. History of heparin-induced thrombocytopenia (HIT) that cannot be treated with direct&#xD;
             thrombin inhibitors.&#xD;
&#xD;
         16. Any thrombolytic therapy within two weeks prior to enrollment.&#xD;
&#xD;
         17. Psychiatric disorder which in the judgment of the investigator could interfere with&#xD;
             provision of informed consent, completion of tests, therapy, follow-up or general&#xD;
             study compliance&#xD;
&#xD;
             Angiographic Exclusion Criteria&#xD;
&#xD;
             Unless otherwise specified, the Investigator performing the procedure bases&#xD;
             angiographic exclusion on visual determination of qualification imaging taken up to 6&#xD;
             months prior to procedure and/or imaging taken at time of procedure. Subject is&#xD;
             excluded if ANY of the following angiographic exclusion criteria is met:&#xD;
&#xD;
         18. Has significant stenos is or occlusion of inflow tract ( upstream disease)&#xD;
             unsuccessfully treated at time of index procedure or presenting symptoms such as&#xD;
             embolism confirmed by angiography.&#xD;
&#xD;
         19. Has in a native vessel, a previously stented segment separated by &lt; 3 cm of&#xD;
             angiographically normal vessel from the target CTO.&#xD;
&#xD;
         20. CTOs lacking at least one patent target distal artery (::;SO% diameter stenosis).&#xD;
&#xD;
         21. Has an acute or sub-acute intraluminal thrombus within the target vessel.&#xD;
&#xD;
         22. Aneurysm distal to puncture access site at least twice the reference vessel diameter,&#xD;
             located in the index vessel, abdominal aorta, iliac or popliteal.&#xD;
&#xD;
         23. Has perforation, dissection or other injury of the access site or index vessel&#xD;
             requiring stenting or surgical intervention prior attempting crossing of the target&#xD;
             lesion with SoundBite™ Crossing System.&#xD;
&#xD;
         24. Clinical/angiographic evidence of distal embolization in the index extremity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UNC Rex Healthcare</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM-Hôtel-Dieu du Centre Hospitalier Universitaire de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2W 1T8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>April 24, 2019</last_update_submitted>
  <last_update_submitted_qc>April 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Total Occlusion</keyword>
  <keyword>Peripheral</keyword>
  <keyword>SoundBite™ Crossing System</keyword>
  <keyword>CTO</keyword>
  <keyword>intra-luminal</keyword>
  <keyword>Active wire</keyword>
  <keyword>Device</keyword>
  <keyword>Procedure</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 28, 2020</submitted>
    <submission_canceled>November 3, 2020</submission_canceled>
  </pending_results>
  <!-- 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/NCT03266835
org study id: NAP-PER-2017-01
nct id: NCT03266835
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This study is aimed at demonstrating the efficacy and safety of the SoundBite™ Crossing
      System-Peripheral. The study is intended to demonstrate that the SoundBite™ Crossing System
      can facilitate the passage of either devices intended to treat a chronic total occlusion
      (CTO) or additional crossing devices through an infrainguinal CTO into the true lumen.
This is a multinational, single-arm, pivotal trial assessing the efficacy and safety of the
      SoundBite™ Crossing System - Peripheral. The enrollment will consist of up to 100 patients
      meeting the inclusion/exclusion criteria in order to obtain 90 evaluable patients for
      efficacy and safety analysis. The primary endpoints will be compared to literature-based
      performance goals to establish study success.

      Objective Performance Goals (OPG) have been obtained from a literature based review. Reports
      published in the past 10 years were reviewed for both safety and effectiveness in crossing
      infrainguinal CTO. The studies reviewed generally have one primary composite safety endpoint
      and one primary efficacy endpoint. Some studies have performed formal hypothesis testing
      versus a pre-specified performance goal for one or both endpoints.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Technical Device Success
time frame: Day 1
description: Ability to facilitate treatment of the target lesion by allowing additional crossing and/or treatment devices to cross the CTO
measure: Freedom from SoundBite™ Crossing System related MAEs at 30 days post procedure
time frame: up to Day 30
description: MAEs defined as:
Cardiovascular related deaths
Unplanned, index limb amputation
Dissection of grade C or greater that require an intervention to resolve
Symptomatic distal embolization, defined as clinical signs or symptoms of distal emboli detected in the treated limb distal to the treated lesion after the index procedure or noted angiographically after the index procedure, and requiring mechanical or pharmacologic means to improve flow
measure: Procedural success
time frame: Day 1
description: Achievement of Technical Success together with post-procedural patency. Post-procedural patency is defined as less then or equal to 50% residual percent diameter stenosis assessed by visual estimate at the end of revascularization procedure
measure: Clinical Success
time frame: Up to Day 30
description: Achievement of Procedural Success as well as freedom from SoundBite™ Crossing System related MAEs at 30 days
measure: Penetration ≥ 0.5 cm
time frame: Day 1
description: Ability of the SoundBite™ Crossing System to penetrate ≥ 0.5 cm of any segment of the CTO
measure: Fully traverse
time frame: Day 1
description: Ability of the SoundBite™ Crossing System to fully traverse the CTO with entry into the distal true lumen without the need for additional guidewires and/or re-entry devices
measure: Freedom from any SoundBite™ Crossing System related Adverse Events
time frame: Up to Day 30
description: Freedom from any SoundBite™ Crossing System related Adverse Events
arm group label: SoundBite™ Crossing System - Peripheral
arm group type: Other
description: This is a multinational, single-arm, pivotal trial assessing the efficacy and safety of the SoundBite™ Crossing System with subjects diagnosed with de novo infrainguinal arterial chronic total occlusion(s).
intervention type: Device
intervention name: SoundBite™ Crossing System - Peripheral
description: SoundBite™ Crossing System consisting of the SoundBite™ Console and SoundBite™ Active Wire 18. The Investigator may use the SoundBite™ Active Wire during the procedure to cross the proximal aspect and/or to cross multiple lesions.
arm group label: SoundBite™ Crossing System - Peripheral
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
sharing ipd: No
submitted: October 28, 2020
submission canceled: November 3, 2020