International BPA Registry

June 9, 2022 updated by: International CTEPH Association
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • University Clinics
  • Belgium
      • Leuven, Belgium
        • Universitaire Ziekenhuizen Leuven
  • Czechia
      • Prague, Czechia
        • General University Hospital
  • France
      • Grenoble, France
        • Centre Hospitalier Universitaire Grenoble-Alpes
      • Le Plessis-Robinson, France
        • L'Hôpital Marie Lannelongue
  • Germany
      • Bad Nauheim, Germany
        • Kerckhoff-Klinik GmbH
  • Japan
      • Okayama, Japan
        • National Hospital Organization Okayama Medical Center
      • Osaka, Japan
        • National Cerebral and Cardiovascular Center
      • Tokyo, Japan
        • Kyorin University Hospital
      • Tokyo, Japan
        • Keio University Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • VU Medical Center
  • Poland
      • Warsaw, Poland
        • European Health Center Otwock LLC
  • United Kingdom
      • Cambridge, United Kingdom
        • Papworth Hospital
  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with CTEPH meeting the inclusion criteria listed below and scheduled to undergo BPA intervention are eligible for inclusion into the International BPA Registry.

Description

Inclusion Criteria:

  • Diagnosis with CTEPH according to the following criteria:

    • Mean PAP ≥ 25mmHg at rest; or if mean PAP < 25mmHg at rest, have exercise limitations from chronic thromboembolic disease
    • Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
  • Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
  • Naïve to BPA treatment
  • Scheduled to undergo their first BPA session ≥ 1 day after enrollment. Enrollment is defined as date the consent is signed by the patient. Enrollment must occur before any BPA session
  • Willing to provide informed consent

Exclusion Criteria:

  • BPA treatment prior to enrollment
  • Pulmonary hypertension cause other than World Health Organization (WHO) group IV (CTEPH)
  • Targeted BPA treatment lesion other than from WHO group IV (CTEPH)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety as assessed by BPA-associated complications
Time Frame: Min. 2 years
Min. 2 years
Efficacy as assessed by change in PVR
Time Frame: Min. 2 years
Change in pulmonary vascular resistance (PVR) from baseline to latest post-interventional follow-up hemodynamics
Min. 2 years
Efficacy as assessed by change in mPAP
Time Frame: Min. 2 years
Change in mean pulmonary arterial pressure (mPAP) from baseline to latest post-interventional follow-up hemodynamics
Min. 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare volume of BPA cases across regions and case load at the end of recruitment
Time Frame: Min. 2 years
Min. 2 years
Analyze patient selection criteria for BPA across sites at the end of recruitment
Time Frame: Min. 2 years
Min. 2 years
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
Imaging modalities encompass VQ scan, selective pulmonary angiogram, CT pulmonary angiogram, dual-energy CT, cone-beam CT, MRI, OCT and IVUS
Min. 2 years
At the end of follow-up, compare technical aspects of BPA as assessed by investigator-reported session goals
Time Frame: Min. 2 years
Min. 2 years
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
Min. 2 years
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
Min. 2 years
At the end of follow-up, compare technical aspects of BPA as assessed by technical limits
Time Frame: Min. 2 years
Min. 2 years
Analyze the use of PH targeted medical therapy before BPA
Time Frame: Min. 2 years
PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other
Min. 2 years
Analyze the use of PH targeted medical therapy after BPA
Time Frame: Min. 2 years
PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other
Min. 2 years
Analyze the impact of PH targeted medical treatment on key patient outcomes
Time Frame: Min. 2 years
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
Min. 2 years
Health care resource use required to complete BPA
Time Frame: Min. 2 years
As assessed by total hospital days in/out
Min. 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International CTEPH Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nick H Kim, Prof, International CTEPH Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BPA registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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