Study Results
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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COMPLETED
500 participants
OBSERVATIONAL
2018-03-02
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* Pulmonary hypertension cause other than World Health Organization (WHO) group IV (CTEPH)
* Targeted BPA treatment lesion other than from WHO group IV (CTEPH)
ALL
No
Sponsors
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International CTEPH Association
OTHER
Responsible Party
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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
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University Clinics
Vienna, , Austria
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
General University Hospital
Prague, , Czechia
Centre Hospitalier Universitaire Grenoble-Alpes
Grenoble, , France
L'Hôpital Marie Lannelongue
Le Plessis-Robinson, , France
Kerckhoff-Klinik GmbH
Bad Nauheim, , Germany
National Hospital Organization Okayama Medical Center
Okayama, , Japan
National Cerebral and Cardiovascular Center
Osaka, , Japan
Keio University Hospital
Tokyo, , Japan
Kyorin University Hospital
Tokyo, , Japan
VU Medical Center
Amsterdam, , Netherlands
European Health Center Otwock LLC
Warsaw, , Poland
Papworth Hospital
Cambridge, , United Kingdom
Countries
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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.
Related Links
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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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