International BPA Registry

NCT ID: NCT03245268

Last Updated: 2022-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-02

Study Completion Date

2022-03-31

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).

Detailed Description

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Conditions

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Chronic Thromboembolic Pulmonary Hypertension CTEPH

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Balloon pulmonary angioplasty

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

Intervention Type PROCEDURE

Other Intervention Names

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BPA

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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International CTEPH Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nick H Kim, Prof

Role: PRINCIPAL_INVESTIGATOR

International CTEPH Association

Locations

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University of California San Diego

La Jolla, California, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

University Clinics

Vienna, , Austria

Site Status

Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Site Status

General University Hospital

Prague, , Czechia

Site Status

Centre Hospitalier Universitaire Grenoble-Alpes

Grenoble, , France

Site Status

L'Hôpital Marie Lannelongue

Le Plessis-Robinson, , France

Site Status

Kerckhoff-Klinik GmbH

Bad Nauheim, , Germany

Site Status

National Hospital Organization Okayama Medical Center

Okayama, , Japan

Site Status

National Cerebral and Cardiovascular Center

Osaka, , Japan

Site Status

Keio University Hospital

Tokyo, , Japan

Site Status

Kyorin University Hospital

Tokyo, , Japan

Site Status

VU Medical Center

Amsterdam, , Netherlands

Site Status

European Health Center Otwock LLC

Warsaw, , Poland

Site Status

Papworth Hospital

Cambridge, , United Kingdom

Site Status

Countries

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

References

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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.

Reference Type DERIVED
PMID: 37405334 (View on PubMed)

Related Links

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https://www.cteph-association.org/

Website of the International CTEPH Association

Other Identifiers

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BPA Registry

Identifier Type: -

Identifier Source: org_study_id

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