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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03245268
Other study ID # BPA Registry
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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