<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/NCT04414332</url>
  </required_header>
  <id_info>
    <org_study_id>2015-SEP-1 Amendment 5</org_study_id>
    <nct_id>NCT04414332</nct_id>
  </id_info>
  <brief_title>Registry of Angiovac Procedures In Detail Outcomes Database-RAPID Registry</brief_title>
  <acronym>RAPID</acronym>
  <official_title>Registry of Angiovac Procedures In Detail Outcomes Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</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>
      Venous thromboembolic disease is a significant cause of morbidity and mortality. The purpose&#xD;
      of the RAPID registry is to collect information on the Angiovac procedure and Angiovac device&#xD;
      used in the treatment of deep venous thrombosis (DVT), right heart pathology and pulmonary&#xD;
      embolism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Venous thromboembolic disease is a significant cause of morbidity and mortality. Thrombolytic&#xD;
      therapy has been shown to be a successful treatment modality, however its use is somewhat&#xD;
      limited due to the known risk of hemorrhage (overall 22%, with up to 3% intracranial&#xD;
      hemorrhage), and suggested risk of distal embolization where large mobile thrombi are&#xD;
      encountered. In patients where either thrombolysis is contraindicated or unsuccessful and&#xD;
      conventional therapies inadequate, bulk thrombectomy may be considered. Until recently this&#xD;
      was primarily achieved with surgical thrombectomy; however the Angiovac device is posited to&#xD;
      offer a minimally invasive alternative.&#xD;
&#xD;
      This registry will collect data on patients in whom the Angiovac device was placed into the&#xD;
      body for management of inferior vena cava (IVC) clots, right atrial (RA) masses or pulmonary&#xD;
      emboli (PE) will be included.&#xD;
&#xD;
      This registry is to capture high quality patient safety and effectiveness data on use of the&#xD;
      Angiovac device for 3 separate, but overlapping conditions; a) Iliofemoral and Caval DVT, b)&#xD;
      Right heart masses, and c) PE. The goal will be achieved by capturing a concise set of&#xD;
      immediate and short-term functional and clinical outcome data for all patients who have the&#xD;
      angiovac catheter deployed into the vascular system.&#xD;
&#xD;
      Any center performing Angiovac procedure and wishing to contribute patient data will be&#xD;
      offered participation in the registry. These core sites will be required to submit the&#xD;
      registry protocol for Institutional Review Board (IRB) review. Once documentation of IRB&#xD;
      approval has been received, centers may transmit their data via secure REDCap (Research&#xD;
      Electronic Data Capture) database in accordance with federal regulations in the Health&#xD;
      Insurance Portability and Accountability Act (HIPAA&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Actual">February 27, 2020</completion_date>
  <primary_completion_date type="Actual">February 27, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Post procedure outcomes</measure>
    <time_frame>Procedure and up to 24 hours post procedure</time_frame>
    <description>to collect information on the Angiovac procedure and Angiovac device used in the treatment of deep venous thrombosis (DVT), right heart pathology and pulmonary embolism.</description>
  </primary_outcome>
  <enrollment type="Actual">234</enrollment>
  <condition>Venous Thromboembolic Disease</condition>
  <condition>Deep Venous Thrombosis</condition>
  <condition>Right Heart Pathology</condition>
  <condition>Pulmonary Embolism</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection only</intervention_name>
    <description>This registry is to capture high quality patient safety and effectiveness data on use of the Angiovac device for 3 separate, but overlapping conditions; a) Iliofemoral and Caval DVT, b) Right heart masses, and c) PE. The goal will be achieved by capturing a concise set of immediate and short-term functional and clinical outcome data for all patients who have the angiovac catheter deployed into the vascular system.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients ages 18 years and older in whom the Angiovac device was deployed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients in whom the Angiovac device was placed into the body for removal of&#xD;
             fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Angiovac device not deployed&#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>John Moriarty, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>John Moriarty, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>inferior vena cava (IVC) clots</keyword>
  <keyword>right atrial (RA) masses</keyword>
  <keyword>pulmonary emboli (PE)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Share de-identified information regarding procedure specifics as per case report forms and procedure outcomes</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>as per individual contract</ipd_time_frame>
  </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/NCT04414332
org study id: 2015-SEP-1 Amendment 5
nct id: NCT04414332
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Venous thromboembolic disease is a significant cause of morbidity and mortality. The purpose
      of the RAPID registry is to collect information on the Angiovac procedure and Angiovac device
      used in the treatment of deep venous thrombosis (DVT), right heart pathology and pulmonary
      embolism.
Venous thromboembolic disease is a significant cause of morbidity and mortality. Thrombolytic
      therapy has been shown to be a successful treatment modality, however its use is somewhat
      limited due to the known risk of hemorrhage (overall 22%, with up to 3% intracranial
      hemorrhage), and suggested risk of distal embolization where large mobile thrombi are
      encountered. In patients where either thrombolysis is contraindicated or unsuccessful and
      conventional therapies inadequate, bulk thrombectomy may be considered. Until recently this
      was primarily achieved with surgical thrombectomy; however the Angiovac device is posited to
      offer a minimally invasive alternative.

      This registry will collect data on patients in whom the Angiovac device was placed into the
      body for management of inferior vena cava (IVC) clots, right atrial (RA) masses or pulmonary
      emboli (PE) will be included.

      This registry is to capture high quality patient safety and effectiveness data on use of the
      Angiovac device for 3 separate, but overlapping conditions; a) Iliofemoral and Caval DVT, b)
      Right heart masses, and c) PE. The goal will be achieved by capturing a concise set of
      immediate and short-term functional and clinical outcome data for all patients who have the
      angiovac catheter deployed into the vascular system.

      Any center performing Angiovac procedure and wishing to contribute patient data will be
      offered participation in the registry. These core sites will be required to submit the
      registry protocol for Institutional Review Board (IRB) review. Once documentation of IRB
      approval has been received, centers may transmit their data via secure REDCap (Research
      Electronic Data Capture) database in accordance with federal regulations in the Health
      Insurance Portability and Accountability Act (HIPAA
observational model: Cohort
time perspective: Prospective
measure: Post procedure outcomes
time frame: Procedure and up to 24 hours post procedure
description: to collect information on the Angiovac procedure and Angiovac device used in the treatment of deep venous thrombosis (DVT), right heart pathology and pulmonary embolism.
intervention type: Other
intervention name: Data collection only
description: This registry is to capture high quality patient safety and effectiveness data on use of the Angiovac device for 3 separate, but overlapping conditions; a) Iliofemoral and Caval DVT, b) Right heart masses, and c) PE. The goal will be achieved by capturing a concise set of immediate and short-term functional and clinical outcome data for all patients who have the angiovac catheter deployed into the vascular system.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Moriarty, MD
role: Principal Investigator
affiliation: Professor
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: John Moriarty, MD
investigator title: Principal Investigator
mesh term: Pulmonary Embolism
mesh term: Thrombosis
mesh term: Embolism
mesh term: Venous Thrombosis
mesh term: Thromboembolism
sharing ipd: Yes
ipd description: Share de-identified information regarding procedure specifics as per case report forms and procedure outcomes
ipd info type: Study Protocol
ipd time frame: as per individual contract