International BPA Registry

NCT03245268 | Completed

• 1 other identifier: BPA Registry
• Study Type: observational
• Target: 500
• Locations: 10 countries
• Sites: 18

Brief 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).

Conditions

Chronic Thromboembolic Pulmonary Hypertension; CTEPH

Keywords

Balloon pulmonary angioplasty; BPA

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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

  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

Interventions

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.

Also known as: BPA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• International CTEPH Association: lead

Study Sites (18)

University of California San Diego

La Jolla, California, 92093, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University Clinics

Vienna, Austria

Location

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Location

General University Hospital

Prague, Czechia

Location

Centre Hospitalier Universitaire Grenoble-Alpes

Grenoble, France

Location

L'Hôpital Marie Lannelongue

Le Plessis-Robinson, France

Location

Kerckhoff-Klinik GmbH

Bad Nauheim, Germany

Location

National Hospital Organization Okayama Medical Center

Okayama, Japan

Location

National Cerebral and Cardiovascular Center

Osaka, Japan

Location

Keio University Hospital

Tokyo, Japan

Location

Kyorin University Hospital

Tokyo, Japan

Location

VU Medical Center

Amsterdam, Netherlands

Location

European Health Center Otwock LLC

Warsaw, Poland

Location

Papworth Hospital

Cambridge, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37405334 DERIVED

Related Links

• Website of the International CTEPH Association

Study Officials

• Nick H Kim, Prof

  International CTEPH Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 10, 2017
• Study Start: March 2, 2018
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

AU (1); FR (2); GB (1); CZ (1); JP (4); NL (1); DE (1); US (5); BE (1); PL (1)