xml: <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/NCT06041594</url>
    </required_header>
    <id_info>
      <org_study_id>CIP-001 Rev. A</org_study_id>
      <nct_id>NCT06041594</nct_id>
    </id_info>
    <brief_title>Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)</brief_title>
    <acronym>TRUST</acronym>
    <official_title>Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Innova Vascular, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Innova Vascular, 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, multi-center, pivotal study to demonstrate the safety and&#xD;
        effectiveness of the Laguna Thrombectomy System for the treatment of pulmonary embolism. The&#xD;
        Laguna Thrombectomy System is an investigational device which consists of the Laguna Clot&#xD;
        Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are manufactured&#xD;
        by Innova Vascular, Inc.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>A composite of the following major adverse events occurring within 48 (± 8) hours post-procedure:</measure>
      <time_frame>within 48 (± 8) hours post-procedure</time_frame>
      <description>Device-related death within 48 (± 8) hours post-procedure&#xD;
  Major bleeding as defined by GUSTO (moderate or severe) within 48 (± 8) hours post-procedure.&#xD;
  The following treatment-related adverse events within 48 (± 8) hours post-procedure:&#xD;
  Cardio-respiratory deterioration,&#xD;
  Pulmonary vascular injury, and/or&#xD;
  Cardiac injury</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reduction in RV/LV ratio from baseline to 48 (± 8) hours (or at discharge, whichever occurs first) as assessed by Computed Tomography Angiography (CTA)</measure>
      <time_frame>from baseline to 48 (± 8) hours (or at discharge, whichever occurs first)</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">107</enrollment>
    <condition>Pulmonary Embolism</condition>
    <arm_group>
      <arm_group_label>Laguna Thrombectomy System</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Laguna Thrombectomy System</intervention_name>
      <description>Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism</description>
      <arm_group_label>Laguna Thrombectomy System</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. ≥ 18 years of age; &lt; 85 years old&#xD;
  &#xD;
            2. RV/LV ratio &gt; 0.9 as determined by CTA&#xD;
  &#xD;
            3. Systolic blood pressure &gt; 90 mmHg&#xD;
  &#xD;
            4. Heart rate ≤ 120&#xD;
  &#xD;
            5. Patient is deemed eligible for procedure by the interventional investigator&#xD;
  &#xD;
            6. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary&#xD;
               artery)&#xD;
  &#xD;
            7. PE Symptom duration ≤ 14 days&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Systolic pulmonary artery pressure &gt; 70 mmHg on initial invasive hemodynamic&#xD;
               assessments&#xD;
  &#xD;
            2. Life expectancy of &lt; 90 days in the opinion of investigator at the time of enrollment&#xD;
  &#xD;
            3. Subject pregnant or breast feeding&#xD;
  &#xD;
            4. Current participation in another drug or medical device treatment study&#xD;
  &#xD;
            5. In active chemotherapy or radiation treatment for a malignancy during the course of&#xD;
               the study&#xD;
  &#xD;
            6. Any intravascular administration of a fibrinolytic agent (such as Alteplase or&#xD;
               Tenecteplase) within the last 30 days&#xD;
  &#xD;
            7. Presence of recently placed (&lt;8 weeks) intracardiac devices (such as pacemaker leads)&#xD;
               in the right ventricle or right atrium&#xD;
  &#xD;
            8. History of prior PE within the past 90 days&#xD;
  &#xD;
            9. FiO2 Requirement: &gt; 40% (6 LPM) to keep oxygen saturation &gt; 90%&#xD;
  &#xD;
           10. Hematocrit: &lt; 28%&#xD;
  &#xD;
           11. Platelets: &lt; 100,000/microliter&#xD;
  &#xD;
           12. Serum Creatinine: &gt; 2 mg/dL&#xD;
  &#xD;
           13. International Normalized Ratio (INR): &gt; 3&#xD;
  &#xD;
           14. Major Trauma Injury Severity Score (ISS): &gt; 15&#xD;
  &#xD;
           15. Cardiovascular or pulmonary surgery within the last 7 days&#xD;
  &#xD;
           16. Known bleeding diathesis or coagulation disorder that cannot be managed with&#xD;
               anti-coagulation&#xD;
  &#xD;
           17. History of known severe or chronic pulmonary arterial hypertension&#xD;
  &#xD;
           18. History or chronic left heart disease with left ventricular ejection fraction &lt; 30%&#xD;
  &#xD;
           19. History of underlying lung disease that is oxygen dependent&#xD;
  &#xD;
           20. History of chest irradiation&#xD;
  &#xD;
           21. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated&#xD;
  &#xD;
           22. Any absolute contraindication to systemic or therapeutic dosage of heparin or&#xD;
               anticoagulants&#xD;
  &#xD;
           23. Imaging or other evidence that suggests, in the opinion of the investigator, the&#xD;
               subject is not appropriate for mechanical thrombectomy intervention (e.g., inability&#xD;
               to navigate to target location, predominantly chronic clot or non-clot embolus)&#xD;
  &#xD;
           24. Known presence of clot in transit within right atrium or ventricle&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sanjay Shrivastava, Ph.D.</last_name>
      <phone>949-295-6040</phone>
      <email>ss@innovavascular.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Laguna Thrombectomy System</keyword>
    <keyword>Pulmonary Embolism</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulmonary Embolism</mesh_term>
      <mesh_term>Embolism</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041594
  org study id: CIP-001 Rev. A
  nct id: NCT06041594
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  This is a prospective, multi-center, pivotal study to demonstrate the safety and
        effectiveness of the Laguna Thrombectomy System for the treatment of pulmonary embolism. The
        Laguna Thrombectomy System is an investigational device which consists of the Laguna Clot
        Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are manufactured
        by Innova Vascular, Inc.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: A composite of the following major adverse events occurring within 48 (± 8) hours post-procedure:
  time frame: within 48 (± 8) hours post-procedure
  description: Device-related death within 48 (± 8) hours post-procedure
  Major bleeding as defined by GUSTO (moderate or severe) within 48 (± 8) hours post-procedure.
  The following treatment-related adverse events within 48 (± 8) hours post-procedure:
  Cardio-respiratory deterioration,
  Pulmonary vascular injury, and/or
  Cardiac injury
  measure: Reduction in RV/LV ratio from baseline to 48 (± 8) hours (or at discharge, whichever occurs first) as assessed by Computed Tomography Angiography (CTA)
  time frame: from baseline to 48 (± 8) hours (or at discharge, whichever occurs first)
  arm group label: Laguna Thrombectomy System
  arm group type: Experimental
  intervention type: Device
  intervention name: Laguna Thrombectomy System
  description: Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism
  arm group label: Laguna Thrombectomy System
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Sanjay Shrivastava, Ph.D.
  phone: 949-295-6040
  email: ss@innovavascular.com
  responsible party type: Sponsor
  mesh term: Pulmonary Embolism
  mesh term: Embolism