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Completed

NCT Number: NCT03245268

International BPA Registry

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).

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Key information

Conditions

Chronic Thromboembolic Pulmonary Hypertension CTEPH

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinics, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Balloon pulmonary angioplasty

Procedure

BPA is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.

Other names: BPA

Primary outcomes

  1. Safety as assessed by BPA-associated complications

    Time frame: Min. 2 years

  2. 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

  3. 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

Secondary outcomes

  1. Compare volume of BPA cases across regions and case load at the end of recruitment

    Time frame: Min. 2 years

  2. Analyze patient selection criteria for BPA across sites at the end of recruitment

    Time frame: Min. 2 years

  3. 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

  4. At the end of follow-up, compare technical aspects of BPA as assessed by investigator-reported session goals

    Time frame: Min. 2 years

  5. 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

  6. 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

  7. At the end of follow-up, compare technical aspects of BPA as assessed by technical limits

    Time frame: Min. 2 years

  8. 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

  9. 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

  10. 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

  11. Health care resource use required to complete BPA

    Time frame: Min. 2 years

    As assessed by total hospital days in/out

Sponsors and collaborators

Lead sponsor

International CTEPH Association

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2017
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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