<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/NCT04473560</url>
  </required_header>
  <id_info>
    <org_study_id>879/19</org_study_id>
    <nct_id>NCT04473560</nct_id>
  </id_info>
  <brief_title>Catheter-directed Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism</brief_title>
  <acronym>CATH-PE</acronym>
  <official_title>Continuous Aspiration Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poznan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poznan University of Medical Sciences</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>
      Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism&#xD;
      may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In&#xD;
      high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development&#xD;
      of interventional cardiology has made catheter-directed techniques an important alternative&#xD;
      to thrombolytic therapy. The controversy concerns also risk stratification and treatment in&#xD;
      intermediate-high risk pulmonary embolism patients. A significant percentage of&#xD;
      intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic&#xD;
      deterioration and then the prognosis in this group is significantly worse. Catheter-directed&#xD;
      techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus&#xD;
      increasing cardiac output and immediately restoring hemodynamic stability.&#xD;
&#xD;
      The scope of this study is to evaluate the safety and feasibility of catheter-directed&#xD;
      approaches in high-risk and intermediate-high risk pulmonary embolism patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism&#xD;
      may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In&#xD;
      high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development&#xD;
      of interventional cardiology has made catheter-directed techniques an important alternative&#xD;
      to thrombolytic therapy. The controversy concerns also risk stratification and treatment in&#xD;
      intermediate-high risk pulmonary embolism patients. A significant percentage of&#xD;
      intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic&#xD;
      deterioration and then the prognosis in this group is significantly worse. Catheter-directed&#xD;
      techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus&#xD;
      increasing cardiac output and immediately restoring hemodynamic stability.&#xD;
&#xD;
      The scope of this study is to evaluate the safety and feasibility of catheter-directed&#xD;
      approaches in high-risk and intermediate-high risk pulmonary embolism patients.&#xD;
&#xD;
      The primary data recorded include details of each patient's clinical status, co-morbidities&#xD;
      with the Charlson Comorbidity Index, the implemented catheter-directed therapy, the results&#xD;
      of additional studies (lab tests results, electrocardiogram, imaging studies), and the&#xD;
      outcome. The study endpoints comprise technical success, clinically relevant&#xD;
      procedure-related complications or bleeding events, classified according to the Valve&#xD;
      Academic Research Consortium-2 guidelines criteria.&#xD;
&#xD;
      Collecting the fore mentioned data allows for clinicians to better manage the pulmonary&#xD;
      embolism patients with increased mortality risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Reduction of pulmonary arterial pressures</measure>
    <time_frame>Immediately after catheter-directed thrombectomy procedure</time_frame>
    <description>Incidence of the reduction of systolic and mean pulmonary arterial pressures (mmHg) more than 10% immediately after CDT procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction of vascular obstruction</measure>
    <time_frame>Immediately after catheter-directed thrombectomy procedure</time_frame>
    <description>Incidence of the at least 50% reduction of vascular obstruction in the angiography assessed with Miller Index score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical improvement during catheter-directed thrombectomy (CDT) procedure</measure>
    <time_frame>Immediately after catheter-directed thrombectomy procedure</time_frame>
    <description>Incidence of arterial blood saturation increase &gt;92%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ventricular strain reduction</measure>
    <time_frame>24 hours after catheter-directed thrombectomy</time_frame>
    <description>Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography 24 hours after the CDT.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Early mortality rate from pulmonary embolism</measure>
    <time_frame>24 hours after catheter-directed thrombectomy</time_frame>
    <description>Number of patients who died from pulmonary embolism (right heart failure) during the first 24 hours after CDT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total mortality rate from pulmonary embolism</measure>
    <time_frame>3 months after catheter-directed thrombectomy</time_frame>
    <description>1. Number of patients who died from pulmonary embolism (right heart failure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding events incidence</measure>
    <time_frame>3 months after catheter-directed thrombectomy</time_frame>
    <description>Incidence of major bleedings assessed using The Valve Academic Research Consortium-2 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events incidence</measure>
    <time_frame>3 months after catheter-directed thrombectomy</time_frame>
    <description>Incidence of pulmonary vascular injury assessed on angiography</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pulmonary Embolism With Acute Cor Pulmonale</condition>
  <arm_group>
    <arm_group_label>Catheter-directed thrombectomy group</arm_group_label>
    <description>Patients with acute pulmonary embolism treated with catheter-directed thrombectomy along with anticoagulation therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No catheter-directed thrombectomy group</arm_group_label>
    <description>Patients with acute pulmonary embolism treated with anticoagulation therapy alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Catheter-directed thrombectomy</intervention_name>
    <description>Using common femoral venous access the pigtail diagnostic catheter will be placed into the main pulmonary artery and an initial pulmonary angiogram will be performed to demonstrate the location and extent of thrombi in pulmonary arteries. Then pulmonary arterial pressures will be measured. Subsequently an Indigo catheter (Penumbra, Alameda, California) will be placed and a direct-aspiration first-pass technique will be performed purposefully to attach a large thrombus to the catheter tip by suction and then pull it out through the sheath. The decision to terminate the intervention will be at operator's discretion after careful evaluation of hemodynamic parameters (restoration of the systolic blood pressure≥100 mmHg, heart rate &lt;100/min), improvement of arterial blood saturation≥ 92%, practicable clot burden reduction and total amount of aspirated blood (no more than 300 ml).</description>
    <arm_group_label>Catheter-directed thrombectomy group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients hospitalized due to high risk or intermediate-high risk pulmonary&#xD;
        embolism.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical symptoms and presentation consistent with pulmonary embolism (PE).&#xD;
&#xD;
          2. PE symptoms duration ≤ 14 days.&#xD;
&#xD;
          3. High risk PE patients with absolute contraindications to systemic thrombolysis or its&#xD;
             failure (refractory circulatory collapse) not eligible for surgical embolectomy.&#xD;
&#xD;
          4. Intermediate-high risk PE patients with right ventricle dysfunction confirmed by&#xD;
             computed tomography pulmonary angiography or transthoracic echocardiography and&#xD;
             elevated troponin level with concomitant at least one of below criterium for minimum&#xD;
             24 hours:&#xD;
&#xD;
               1. Systolic blood pressure &gt; 90 mmHg and ≤ 100 mmHg&#xD;
&#xD;
               2. Heart rate ≥ 110/min,&#xD;
&#xD;
               3. Arterial blood saturation &lt;90% during spontaneous breathing (atm)&#xD;
&#xD;
          5. Intermediate-high risk PE patients with right ventricle dysfunction confirmed by&#xD;
             computed tomography pulmonary angiography or transthoracic echocardiography and&#xD;
             elevated troponin level with sudden occurrence of one or more of the below listed&#xD;
             factors:&#xD;
&#xD;
               1. Systolic blood pressure &gt; 90 mmHg and ≤ 100 mmHg&#xD;
&#xD;
               2. Heart rate≥ 110/min,&#xD;
&#xD;
               3. Arterial blood saturation &lt;90% during spontaneous breathing (atm)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy.&#xD;
&#xD;
          2. Refusal to sign the informed consent form.&#xD;
&#xD;
          3. Presence of intracardiac thrombus.&#xD;
&#xD;
          4. Diagnosed thrombophilia.&#xD;
&#xD;
          5. Severe thrombocytopenia (platelets count below 20 000 µL).&#xD;
&#xD;
          6. History of severe or chronic pulmonary hypertension.&#xD;
&#xD;
          7. Serum creatinine level higher than 1.8 mg/dl.&#xD;
&#xD;
          8. Known serious and uncontrolled sensitivity to radiographic agents.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Aleksander Araszkiewicz, Assoc. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Poznan University of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aleksander Araszkiewicz, Assoc. Prof.</last_name>
    <phone>+488549293</phone>
    <email>aaraszkiewicz@ump.edu.pl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sylwia Sławek-Szmyt, MD, PhD</last_name>
    <phone>+48 8549293</phone>
    <email>sylwia.slawek@skpp.edu.pl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Poznan University of Medical Sciences</name>
      <address>
        <city>Poznan</city>
        <state>Greaterpoland</state>
        <zip>61-701</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aleksander Araszkiewicz, Assoc. Prof.</last_name>
      <email>aaraszkiewicz@ump.edu.pl</email>
    </contact>
    <contact_backup>
      <last_name>Sylwia Sławek-Szmyt</last_name>
      <email>sylwia.slawek@skpp.edu.pl</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>August 14, 2020</last_update_submitted>
  <last_update_submitted_qc>August 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Poznan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Aleksander Araszkiewicz</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <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>
    <mesh_term>Pulmonary Heart Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underline the results reported in this study, after deidentification (text, figures, tables and appendices)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Beginning just after study results publication and ending 24 months following study results publication</ipd_time_frame>
    <ipd_access_criteria>Investigators who provide a methodologically sound proposal. Proposals should be submitted to aaraszkiewicz@ump.edu.pl</ipd_access_criteria>
  </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/NCT04473560
org study id: 879/19
nct id: NCT04473560
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism
      may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In
      high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development
      of interventional cardiology has made catheter-directed techniques an important alternative
      to thrombolytic therapy. The controversy concerns also risk stratification and treatment in
      intermediate-high risk pulmonary embolism patients. A significant percentage of
      intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic
      deterioration and then the prognosis in this group is significantly worse. Catheter-directed
      techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus
      increasing cardiac output and immediately restoring hemodynamic stability.

      The scope of this study is to evaluate the safety and feasibility of catheter-directed
      approaches in high-risk and intermediate-high risk pulmonary embolism patients.
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism
      may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In
      high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development
      of interventional cardiology has made catheter-directed techniques an important alternative
      to thrombolytic therapy. The controversy concerns also risk stratification and treatment in
      intermediate-high risk pulmonary embolism patients. A significant percentage of
      intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic
      deterioration and then the prognosis in this group is significantly worse. Catheter-directed
      techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus
      increasing cardiac output and immediately restoring hemodynamic stability.

      The scope of this study is to evaluate the safety and feasibility of catheter-directed
      approaches in high-risk and intermediate-high risk pulmonary embolism patients.

      The primary data recorded include details of each patient's clinical status, co-morbidities
      with the Charlson Comorbidity Index, the implemented catheter-directed therapy, the results
      of additional studies (lab tests results, electrocardiogram, imaging studies), and the
      outcome. The study endpoints comprise technical success, clinically relevant
      procedure-related complications or bleeding events, classified according to the Valve
      Academic Research Consortium-2 guidelines criteria.

      Collecting the fore mentioned data allows for clinicians to better manage the pulmonary
      embolism patients with increased mortality risk.
observational model: Case-Control
time perspective: Prospective
measure: Reduction of pulmonary arterial pressures
time frame: Immediately after catheter-directed thrombectomy procedure
description: Incidence of the reduction of systolic and mean pulmonary arterial pressures (mmHg) more than 10% immediately after CDT procedure.
measure: Reduction of vascular obstruction
time frame: Immediately after catheter-directed thrombectomy procedure
description: Incidence of the at least 50% reduction of vascular obstruction in the angiography assessed with Miller Index score
measure: Clinical improvement during catheter-directed thrombectomy (CDT) procedure
time frame: Immediately after catheter-directed thrombectomy procedure
description: Incidence of arterial blood saturation increase >92%
measure: Ventricular strain reduction
time frame: 24 hours after catheter-directed thrombectomy
description: Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography 24 hours after the CDT.
measure: Early mortality rate from pulmonary embolism
time frame: 24 hours after catheter-directed thrombectomy
description: Number of patients who died from pulmonary embolism (right heart failure) during the first 24 hours after CDT.
measure: Total mortality rate from pulmonary embolism
time frame: 3 months after catheter-directed thrombectomy
description: 1. Number of patients who died from pulmonary embolism (right heart failure)
measure: Bleeding events incidence
time frame: 3 months after catheter-directed thrombectomy
description: Incidence of major bleedings assessed using The Valve Academic Research Consortium-2 criteria
measure: Adverse events incidence
time frame: 3 months after catheter-directed thrombectomy
description: Incidence of pulmonary vascular injury assessed on angiography
arm group label: Catheter-directed thrombectomy group
description: Patients with acute pulmonary embolism treated with catheter-directed thrombectomy along with anticoagulation therapy
arm group label: No catheter-directed thrombectomy group
description: Patients with acute pulmonary embolism treated with anticoagulation therapy alone
intervention type: Device
intervention name: Catheter-directed thrombectomy
description: Using common femoral venous access the pigtail diagnostic catheter will be placed into the main pulmonary artery and an initial pulmonary angiogram will be performed to demonstrate the location and extent of thrombi in pulmonary arteries. Then pulmonary arterial pressures will be measured. Subsequently an Indigo catheter (Penumbra, Alameda, California) will be placed and a direct-aspiration first-pass technique will be performed purposefully to attach a large thrombus to the catheter tip by suction and then pull it out through the sheath. The decision to terminate the intervention will be at operator's discretion after careful evaluation of hemodynamic parameters (restoration of the systolic blood pressure≥100 mmHg, heart rate <100/min), improvement of arterial blood saturation≥ 92%, practicable clot burden reduction and total amount of aspirated blood (no more than 300 ml).
arm group label: Catheter-directed thrombectomy group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Aleksander Araszkiewicz, Assoc. Prof.
role: Principal Investigator
affiliation: Poznan University of Medical Sciences
last name: Aleksander Araszkiewicz, Assoc. Prof.
phone: +488549293
email: aaraszkiewicz@ump.edu.pl
last name: Sylwia Sławek-Szmyt, MD, PhD
phone: +48 8549293
email: sylwia.slawek@skpp.edu.pl
facility: 
status: Recruiting
contact: 
contact backup: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Poznan University of Medical Sciences
investigator full name: Aleksander Araszkiewicz
investigator title: Associate Professor of Medicine
mesh term: Pulmonary Embolism
mesh term: Embolism
mesh term: Pulmonary Heart Disease
sharing ipd: Yes
ipd description: Individual participant data that underline the results reported in this study, after deidentification (text, figures, tables and appendices)
ipd info type: Study Protocol
ipd time frame: Beginning just after study results publication and ending 24 months following study results publication
ipd access criteria: Investigators who provide a methodologically sound proposal. Proposals should be submitted to aaraszkiewicz@ump.edu.pl