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/NCT05992168</url>
    </required_header>
    <id_info>
      <org_study_id>SZZT-CP-202301</org_study_id>
      <nct_id>NCT05992168</nct_id>
    </id_info>
    <brief_title>Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME)</brief_title>
    <acronym>SRAME</acronym>
    <official_title>A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Thrombectomy Devices for the Treatment of Acute Pulmonary Embolism</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Suzhou Zenith Vascular Scitech Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Suzhou Zenith Vascular Scitech Co., Ltd.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To evaluate treatment outcomes of patients diagnosed with pulmonary embolism.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 15, 2023</start_date>
    <completion_date type="Anticipated">June 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 15, 2025</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>Reduction in RV/LV ratio from baseline to 48 hours</measure>
      <time_frame>48 hours post procedure</time_frame>
      <description>Endpoint events will be assessed from the time of treatment of the pulmonary embolism through hospital discharge, or through 48 hours post treatment, whichever comes first.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Major Adverse Events from baseline to 48 hours</measure>
      <time_frame>48 hours post procedure</time_frame>
      <description>Endpoint events will be assessed from the time of treatment of the pulmonary embolism through hospital discharge, or through 48 hours post treatment, whichever comes first.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">123</enrollment>
    <condition>PE - Pulmonary Embolism</condition>
    <condition>PE - Pulmonary Thromboembolism</condition>
    <arm_group>
      <arm_group_label>Stent-Retriever arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Device: Stent-Retriever</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Stent-Retriever</intervention_name>
      <description>all the participants in this group will be performed with Stent-Retriever</description>
      <arm_group_label>Stent-Retriever arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - 1.18≤ age ≤75, no gender limitation; 2.patients clinically diagnosed as acute pulmonary&#xD;
          embolism requiring pulmonary artery thrombosis clearance; 3.RV/LV ratio ≥0.9; 4.Patients&#xD;
          who agreed to participate in the study and voluntarily signed the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with systolic blood pressure&lt;90 mmHg and lasting for 15 minutes or requiring&#xD;
               maintenance of systolic blood pressure ≥ 90 mmHg;&#xD;
  &#xD;
            2. Patients with known severe pulmonary hypertension;&#xD;
  &#xD;
            3. Patients with Hematocrit &lt;28%;&#xD;
  &#xD;
            4. Patients with known structural heart disease;&#xD;
  &#xD;
            5. Patients with left bundle branch block;&#xD;
  &#xD;
            6. Patients with history of chronic left heart failure and left ventricular ejection&#xD;
               fraction ≤30%;&#xD;
  &#xD;
            7. Patients with abnormal renal function (serum creatinine &gt; 1.8 mg/dL or &gt;159 umol/L);&#xD;
  &#xD;
            8. Patients with known coagulopathy or bleeding tendency (platelet &lt;100×109/L, or INR&gt;&#xD;
               3);&#xD;
  &#xD;
            9. Patients who cannot receive antiplatelet or anticoagulant therapy;&#xD;
  &#xD;
           10. Patients who underwent cardiovascular or pulmonary open surgery within 7 days before&#xD;
               peocedure;&#xD;
  &#xD;
           11. Patients with intracardiac thrombosis;&#xD;
  &#xD;
           12. Patients treated with extracorporeal membrane oxygenation;&#xD;
  &#xD;
           13. Patients known to be allergic to contrast agents;&#xD;
  &#xD;
           14. Patients with diseases that may cause difficulty in treatment or evaluation (such as&#xD;
               malignant tumor, acute infectious disease, sepsis, general condition that cannot&#xD;
               tolerate procedure, life expectancy less than one year, etc.);&#xD;
  &#xD;
           15. Females who are pregnant or in lactation;&#xD;
  &#xD;
           16. Patient is currently enrolled in another investigational study protocol;&#xD;
  &#xD;
           17. Other conditions not suitable for inclusion judged by the researcher.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Peking University People'S Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xiaoming Zhang</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</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>Pulmonary Embolism</mesh_term>
      <mesh_term>Embolism</mesh_term>
      <mesh_term>Thromboembolism</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05992168
  org study id: SZZT-CP-202301
  nct id: NCT05992168
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate treatment outcomes of patients diagnosed with pulmonary embolism.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Reduction in RV/LV ratio from baseline to 48 hours
  time frame: 48 hours post procedure
  description: Endpoint events will be assessed from the time of treatment of the pulmonary embolism through hospital discharge, or through 48 hours post treatment, whichever comes first.
  measure: Major Adverse Events from baseline to 48 hours
  time frame: 48 hours post procedure
  description: Endpoint events will be assessed from the time of treatment of the pulmonary embolism through hospital discharge, or through 48 hours post treatment, whichever comes first.
  arm group label: Stent-Retriever arm
  arm group type: Experimental
  description: Device: Stent-Retriever
  intervention type: Device
  intervention name: Stent-Retriever
  description: all the participants in this group will be performed with Stent-Retriever
  arm group label: Stent-Retriever arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Pulmonary Embolism
  mesh term: Embolism
  mesh term: Thromboembolism
  sharing ipd: No