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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 | |
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Inclusion Criteria:
Diagnosis with CTEPH according to the following criteria:
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nick H Kim, Prof | International CTEPH Association | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37405334 | Derived | Lang IM. Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: Clinical Outcomes. Eur Cardiol. 2023 Apr 5;18:e11. doi: 10.15420/ecr.2022.29. eCollection 2023. |
| Label | URL |
|---|---|
| Website of the International CTEPH Association | View source |
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| 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 |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | 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 |