International BPA Registry

International CTEPH Association500 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Chronic Thromboembolic Pulmonary Hypertension CTEPH

Interventions

Balloon pulmonary angioplastyPROCEDURE

BPA is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Locations (18)

University of California San Diego

La Jolla, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Safety as assessed by BPA-associated complications

Time frame: 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

Time frame: 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

Time frame: Min. 2 years

Secondary Outcomes

Compare volume of BPA cases across regions and case load at the end of recruitment

Time frame: Min. 2 years

Analyze patient selection criteria for BPA across sites at the end of recruitment

Time frame: 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

Time frame: Min. 2 years

At the end of follow-up, compare technical aspects of BPA as assessed by investigator-reported session goals

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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