International BPA Registry

Completed

• Conditions: CTEPH; Chronic Thromboembolic Pulmonary Hypertension

• Registration Number: NCT03245268
• Lead Sponsor: International CTEPH Association

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-10
• Study Start: 2018-03-02
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-09
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
At the end of follow-up, compare technical aspects of BPA as assessed by investigator-reported session goals	Min. 2 years
Analyze patient selection criteria for BPA across sites at the end of recruitment	Min. 2 years
Health care resource use required to complete BPA	Min. 2 years	As assessed by total hospital days in/out
At the end of follow-up, compare technical aspects of BPA as asssed by imaging modalities as used by the sites	Min. 2 years	Imaging modalities encompass VQ scan, selective pulmonary angiogram, CT pulmonary angiogram, dual-energy CT, cone-beam CT, MRI, OCT and IVUS
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
Analyze the impact of PH targeted medical treatment on key patient outcomes	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
Compare volume of BPA cases across regions and case load at the end of recruitment	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 after BPA	Min. 2 years	PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other
Analyze the use of PH targeted medical therapy before BPA	Min. 2 years	PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other

Trial Locations

Locations (18)

Kerckhoff-Klinik GmbH; 🇩🇪 Bad Nauheim, Germany

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

General University Hospital; 🇨🇿 Prague, Czechia

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Belgium

Centre Hospitalier Universitaire Grenoble-Alpes; 🇫🇷 Grenoble, France

National Cerebral and Cardiovascular Center; 🇯🇵 Osaka, Japan

L'Hôpital Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, France

National Hospital Organization Okayama Medical Center; 🇯🇵 Okayama, Japan

Kyorin University Hospital; 🇯🇵 Tokyo, Japan

Keio University Hospital; 🇯🇵 Tokyo, Japan

European Health Center Otwock LLC; 🇵🇱 Warsaw, Poland

Papworth Hospital; 🇬🇧 Cambridge, United Kingdom

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

VU Medical Center; 🇳🇱 Amsterdam, Netherlands

University Clinics; 🇦🇹 Vienna, Austria

University of California San Diego; 🇺🇸 La Jolla, California, United States