Recruiting

BPA vs. PEA in CTEPH

ClinicalTrials.gov IDNCT05110066

PhaseNA

Enrollment139

SponsorUniversity of Aarhus

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Chronic Thromboembolic Pulmonary Hypertension

About this study

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.

Interventions

Procedure: Pulmonary endarterectomy — Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass.
Procedure: Balloon pulmonary angioplasty — Percutaneous balloon pulmonary angioplasty is performed using standard percutaneous technique to break the fibrotic clots in the pulmonary arteries using percutaneous transluminal angioplasty balloons.

Primary outcomes

Change in pulmonary vascular resistance (4 months and 12 months)

Eligibility information

Inclusion Criteria: * 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 Criteria: * Life expectancy \<12 months * Co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients pulmonary hypertension * Not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization. * Evaluated at multidisciplinary team conference that changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up is inevitable\* * Known pregnancy or positive urine Human chorionic gonadotropin screening test in fertile women * Previous balloon pulmonary angioplasty or pulmonary endarterectomy

Study locations

Aarhus University Hospital, Aarhus, Denmark
Royal Ppworth, Cambridge, United Kingdom

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.