NCT05110066Recruiting
BPA vs. PEA in CTEPH
Balloon Pulmonary anGiOplasty Versus Pulmonary Endarterectomy in Patients With Chronic ThromboEmbolic Pulmonary Hypertension: a Non-inferiority Randomized Trial
Source: ClinicalTrials.gov · Last updated 29 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 139 (estimated)
- First submitted
- 4 Oct 2021
- Start date
- 1 Apr 2024
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- University of Aarhus
- NCT number
- NCT05110066
What you commit to
- Study type: Interventional
- Planned participants: 139
- From 1 Apr 2024 to the primary completion date, 1 Apr 2027
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous balloon pulmonary angioplasty or pulmonary endarterectomy
Other illness
- 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\*
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| Royal Ppworth Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.