International BPA Registry

Study Overview
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Brief Summary
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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).

Official Title
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International BPA Registry

Conditions
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Chronic Thromboembolic Pulmonary Hypertension, CTEPH

Intervention / Treatment
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* Procedure: Balloon pulmonary angioplasty


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Balloon pulmonary angioplasty|BPA is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPA, Balloon pulmonary angioplasty