International BPA Registry
Completed
Conditions studied: Chronic Thromboembolic Pulmonary Hypertension, CTEPH
In brief
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).
Key facts
- Study ID
- NCT03245268
- Run by
- International CTEPH Association
- People needed
- 500
- Starts
- 2018-03-02
- Expected to finish
- 2022-03-31
- Last updated by the study team
- 2022-06-10
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- University of California San Diego — La Jolla, California, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Temple University Hospital — Philadelphia, Pennsylvania, United States
- University Clinics — Vienna, Austria
- Universitaire Ziekenhuizen Leuven — Leuven, Belgium
- General University Hospital — Prague, Czechia
- Centre Hospitalier Universitaire Grenoble-Alpes — Grenoble, France
- L'Hôpital Marie Lannelongue — Le Plessis-Robinson, France
- Kerckhoff-Klinik GmbH — Bad Nauheim, Germany
- National Hospital Organization Okayama Medical Center — Okayama, Japan
- National Cerebral and Cardiovascular Center — Osaka, Japan
- Keio University Hospital — Tokyo, Japan
- Kyorin University Hospital — Tokyo, Japan
- VU Medical Center — Amsterdam, Netherlands
- European Health Center Otwock LLC — Warsaw, Poland
- Papworth Hospital — Cambridge, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.