RecruitingNot ApplicableNCT05110066

BPA vs. PEA in CTEPH

Balloon Pulmonary anGiOplasty Versus Pulmonary Endarterectomy in Patients With Chronic ThromboEmbolic Pulmonary Hypertension: a Non-inferiority Randomized Trial

Sponsor

University of Aarhus

Enrollment

139 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 79 Years

Inclusion Criteria4

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 Criteria6

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

Interventions

PROCEDUREPulmonary endarterectomy

Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass.

PROCEDUREBalloon 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.