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).

Study Overview

• Status: Completed
• Conditions: Chronic Thromboembolic Pulmonary Hypertension; CTEPH
• Intervention / Treatment: Procedure: Balloon pulmonary angioplasty

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as assessed by BPA-associated complications		Min. 2 years
Efficacy as assessed by change in PVR	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	Change in mean pulmonary arterial pressure (mPAP) from baseline to latest post-interventional follow-up hemodynamics	Min. 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare volume of BPA cases across regions and case load at the end of recruitment		Min. 2 years
Analyze patient selection criteria for BPA across sites at the end of recruitment		Min. 2 years
At the end of follow-up, compare technical aspects of BPA as asssed by imaging modalities as used by the sites	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		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		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		Min. 2 years
At the end of follow-up, compare technical aspects of BPA as assessed by technical limits		Min. 2 years
Analyze the use of PH targeted medical therapy before BPA	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	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	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	As assessed by total hospital days in/out	Min. 2 years

Collaborators and Investigators

• Sponsor: International CTEPH Association
• Investigators: Principal Investigator: Nick H Kim, Prof, International CTEPH Association

Publications and helpful links

Helpful Links

• Website of the International CTEPH Association

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2018
• Primary Completion (ACTUAL): March 31, 2022
• Study Completion (ACTUAL): March 31, 2022

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (ACTUAL): August 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Balloon pulmonary angioplasty; BPA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID 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