<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/NCT03245268</url>
  </required_header>
  <id_info>
    <org_study_id>BPA Registry</org_study_id>
    <nct_id>NCT03245268</nct_id>
  </id_info>
  <brief_title>International BPA Registry</brief_title>
  <official_title>International BPA Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International CTEPH Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>International CTEPH Association</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>
      The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective,&#xD;
      multi-center, long-term observational project. Scheduled to start data collection in Q4 2017,&#xD;
      the registry will run for approximately four years with a follow-up time for each patient of&#xD;
      at least two years. Its primary objective is to investigate the efficacy and safety of BPA&#xD;
      intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not&#xD;
      amenable to pulmonary endarterectomy (PEA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2018</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2022</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>2 Years</target_duration>
  <primary_outcome>
    <measure>Safety as assessed by BPA-associated complications</measure>
    <time_frame>Min. 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy as assessed by change in PVR</measure>
    <time_frame>Min. 2 years</time_frame>
    <description>Change in pulmonary vascular resistance (PVR) from baseline to latest post-interventional follow-up hemodynamics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy as assessed by change in mPAP</measure>
    <time_frame>Min. 2 years</time_frame>
    <description>Change in mean pulmonary arterial pressure (mPAP) from baseline to latest post-interventional follow-up hemodynamics</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare volume of BPA cases across regions and case load at the end of recruitment</measure>
    <time_frame>Min. 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyze patient selection criteria for BPA across sites at the end of recruitment</measure>
    <time_frame>Min. 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>At the end of follow-up, compare technical aspects of BPA as asssed by imaging modalities as used by the sites</measure>
    <time_frame>Min. 2 years</time_frame>
    <description>Imaging modalities encompass VQ scan, selective pulmonary angiogram, CT pulmonary angiogram, dual-energy CT, cone-beam CT, MRI, OCT and IVUS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>At the end of follow-up, compare technical aspects of BPA as assessed by investigator-reported session goals</measure>
    <time_frame>Min. 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>At the end of follow-up, compare technical aspects of BPA as assessed by number of sessions per patient and follow-up</measure>
    <time_frame>Min. 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>At the end of follow-up, compare technical aspects of BPA as assessed by number of interventions per patient and follow-up</measure>
    <time_frame>Min. 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>At the end of follow-up, compare technical aspects of BPA as assessed by technical limits</measure>
    <time_frame>Min. 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyze the use of PH targeted medical therapy before BPA</measure>
    <time_frame>Min. 2 years</time_frame>
    <description>PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyze the use of PH targeted medical therapy after BPA</measure>
    <time_frame>Min. 2 years</time_frame>
    <description>PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyze the impact of PH targeted medical treatment on key patient outcomes</measure>
    <time_frame>Min. 2 years</time_frame>
    <description>PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other Key patient outcomes encompass WHO functional class, 6-minute-walk-distance, Borg dyspnoe score, haemodynamics and mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care resource use required to complete BPA</measure>
    <time_frame>Min. 2 years</time_frame>
    <description>As assessed by total hospital days in/out</description>
  </secondary_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Chronic Thromboembolic Pulmonary Hypertension</condition>
  <condition>CTEPH</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Balloon pulmonary angioplasty</intervention_name>
    <description>BPA is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.</description>
    <other_name>BPA</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with CTEPH meeting the inclusion criteria listed below and scheduled to&#xD;
        undergo BPA intervention are eligible for inclusion into the International BPA Registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis with CTEPH according to the following criteria:&#xD;
&#xD;
               -  Mean PAP ≥ 25mmHg at rest; or if mean PAP &lt; 25mmHg at rest, have exercise&#xD;
                  limitations from chronic thromboembolic disease&#xD;
&#xD;
               -  Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram,&#xD;
                  computer tomographic pulmonary angiogram, or magnetic resonance pulmonary&#xD;
                  angiogram confirming chronic thromboembolic disease as recommended by standard&#xD;
                  guidelines&#xD;
&#xD;
          -  Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH&#xD;
&#xD;
          -  Naïve to BPA treatment&#xD;
&#xD;
          -  Scheduled to undergo their first BPA session ≥ 1 day after enrollment. Enrollment is&#xD;
             defined as date the consent is signed by the patient. Enrollment must occur before any&#xD;
             BPA session&#xD;
&#xD;
          -  Willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BPA treatment prior to enrollment&#xD;
&#xD;
          -  Pulmonary hypertension cause other than World Health Organization (WHO) group IV&#xD;
             (CTEPH)&#xD;
&#xD;
          -  Targeted BPA treatment lesion other than from WHO group IV (CTEPH)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nick H Kim, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>International CTEPH Association</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinics</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaire Ziekenhuizen Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General University Hospital</name>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Grenoble-Alpes</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L'Hôpital Marie Lannelongue</name>
      <address>
        <city>Le Plessis-Robinson</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kerckhoff-Klinik GmbH</name>
      <address>
        <city>Bad Nauheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Okayama Medical Center</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cerebral and Cardiovascular Center</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyorin University Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VU Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>European Health Center Otwock LLC</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Papworth Hospital</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.cteph-association.org/</url>
    <description>Website of the International CTEPH Association</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>June 9, 2022</last_update_submitted>
  <last_update_submitted_qc>June 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Balloon pulmonary angioplasty</keyword>
  <keyword>BPA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
  </condition_browse>
  <!-- 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/NCT03245268
org study id: BPA Registry
nct id: NCT03245268
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective,
      multi-center, long-term observational project. Scheduled to start data collection in Q4 2017,
      the registry will run for approximately four years with a follow-up time for each patient of
      at least two years. Its primary objective is to investigate the efficacy and safety of BPA
      intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not
      amenable to pulmonary endarterectomy (PEA).
observational model: Cohort
time perspective: Prospective
measure: Safety as assessed by BPA-associated complications
time frame: Min. 2 years
measure: Efficacy as assessed by change in PVR
time frame: Min. 2 years
description: Change in pulmonary vascular resistance (PVR) from baseline to latest post-interventional follow-up hemodynamics
measure: Efficacy as assessed by change in mPAP
time frame: Min. 2 years
description: Change in mean pulmonary arterial pressure (mPAP) from baseline to latest post-interventional follow-up hemodynamics
measure: Compare volume of BPA cases across regions and case load at the end of recruitment
time frame: Min. 2 years
measure: Analyze patient selection criteria for BPA across sites at the end of recruitment
time frame: Min. 2 years
measure: At the end of follow-up, compare technical aspects of BPA as asssed by imaging modalities as used by the sites
time frame: Min. 2 years
description: Imaging modalities encompass VQ scan, selective pulmonary angiogram, CT pulmonary angiogram, dual-energy CT, cone-beam CT, MRI, OCT and IVUS
measure: At the end of follow-up, compare technical aspects of BPA as assessed by investigator-reported session goals
time frame: Min. 2 years
measure: At the end of follow-up, compare technical aspects of BPA as assessed by number of sessions per patient and follow-up
time frame: Min. 2 years
measure: At the end of follow-up, compare technical aspects of BPA as assessed by number of interventions per patient and follow-up
time frame: Min. 2 years
measure: At the end of follow-up, compare technical aspects of BPA as assessed by technical limits
time frame: Min. 2 years
measure: Analyze the use of PH targeted medical therapy before BPA
time frame: Min. 2 years
description: PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other
measure: Analyze the use of PH targeted medical therapy after BPA
time frame: Min. 2 years
description: PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other
measure: Analyze the impact of PH targeted medical treatment on key patient outcomes
time frame: Min. 2 years
description: PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other Key patient outcomes encompass WHO functional class, 6-minute-walk-distance, Borg dyspnoe score, haemodynamics and mortality
measure: Health care resource use required to complete BPA
time frame: Min. 2 years
description: As assessed by total hospital days in/out
intervention type: Procedure
intervention name: Balloon pulmonary angioplasty
description: BPA is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.
other name: BPA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nick H Kim, Prof
role: Principal Investigator
affiliation: International CTEPH Association
facility: 
facility: 
facility: 
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country: Austria
country: Belgium
country: Czechia
country: France
country: Germany
country: Japan
country: Netherlands
country: Poland
country: United Kingdom
country: United States
url: https://www.cteph-association.org/
description: Website of the International CTEPH Association
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary