International BPA Registry

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

Official title:

International BPA Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03245268
• Other study ID #: BPA Registry
• Status: Completed
• Start date: March 2, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2022
• Source: International CTEPH Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• CTEPH
• Hypertension, Pulmonary

Intervention

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.

Locations

Country	Name	City	State
Austria	University Clinics	Vienna
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Czechia	General University Hospital	Prague
France	Centre Hospitalier Universitaire Grenoble-Alpes	Grenoble
France	L'Hôpital Marie Lannelongue	Le Plessis-Robinson
Germany	Kerckhoff-Klinik GmbH	Bad Nauheim
Japan	National Hospital Organization Okayama Medical Center	Okayama
Japan	National Cerebral and Cardiovascular Center	Osaka
Japan	Keio University Hospital	Tokyo
Japan	Kyorin University Hospital	Tokyo
Netherlands	VU Medical Center	Amsterdam
Poland	European Health Center Otwock LLC	Warsaw
United Kingdom	Papworth Hospital	Cambridge
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of California San Diego	La Jolla	California
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
International CTEPH Association

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Czechia,  France,  Germany,  Japan,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as assessed by BPA-associated complications		Min. 2 years
Primary	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
Primary	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	Compare volume of BPA cases across regions and case load at the end of recruitment		Min. 2 years
Secondary	Analyze patient selection criteria for BPA across sites at the end of recruitment		Min. 2 years
Secondary	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
Secondary	At the end of follow-up, compare technical aspects of BPA as assessed by investigator-reported session goals		Min. 2 years
Secondary	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
Secondary	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
Secondary	At the end of follow-up, compare technical aspects of BPA as assessed by technical limits		Min. 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Health care resource use required to complete BPA	As assessed by total hospital days in/out	Min. 2 years

External Links

•   Website of the International CTEPH Association