Comparing two procedures for chronic blood clots in the lung arteries
Compares balloon angioplasty with surgery in adults with chronic thromboembolic pulmonary hypertension.
Plain-language title generated from the registry record
Registry title: BPA vs. PEA in CTEPH
Key facts
- Where
- Aarhus, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 79 years old?
Source: NCT05110066, who can take part
Where in Denmark
- Aarhus University HospitalAarhus, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT05110066
- Record updated
- 29 April 2024
- Original description
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and potentially life-threatening progressive disease that evolves from unresolved pulmonary embolism. Gold standard treatment for CTEPH is pulmonary endarterectomy (PEA) performed by skilled cardio-thoracic surgeons.Read full original descriptionShow less
Balloon Pulmonary anGiOplasty Versus Pulmonary Endarterectomy in Patients With Chronic ThromboEmbolic Pulmonary Hypertension: a Non-inferiority Randomized Trial
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and potentially life-threatening progressive disease that evolves from unresolved pulmonary embolism. Gold standard treatment for CTEPH is pulmonary endarterectomy (PEA) performed by skilled cardio-thoracic surgeons.
Some patients may not be surgical candidates due to co-morbidities or because the vascular lesions are too distal making them technically inoperable. In these patients, balloon pulmonary angioplasty (BPA) has emerged as an effective treatment. In a subgroup of patients, the distribution of vascular lesions makes it possible to perform either BPA or PEA. There has never been a head-to head comparison of BPA with PEA. The aim of this study is therefore, to evaluate if BPA is non-inferior to PEA in patients with (CTEPH) who are eligible for both treatments.
Inclusion: Diagnosed with chronic thromboembolic pulmonary hypertension according to current European society of cardiology/European Respiratory Society guidelines and eligible for both pulmonary endarterectomy and ballon pulmonary angioplasty by decision at the local multidisciplinary team conference and central adjudication committee; Written informed consent from the patient; Patient age >17 and <80 years; Able to understand and follow instructions and to participate in the entire study period.
Exclusion: Previous balloon pulmonary angioplasty or pulmonary endarterectomy; Co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients pulmonary hypertension; Evaluated at multidisciplinary team conference that changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up is inevitable*; Life expectancy <12 months; Not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization; Known pregnancy or positive urine Human chorionic gonadotropin screening test in fertile women.