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

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for chronic thromboembolic pulmonary hypertension (CTEPH) — a serious condition where blood clots cause high blood pressure in the lungs: surgical clot removal (pulmonary endarterectomy) versus a minimally invasive balloon procedure (balloon pulmonary angioplasty). **You may be eligible if...** - You have been diagnosed with CTEPH according to current guidelines - A specialist team has determined you are medically suitable for BOTH treatment options - You are between 18 and 80 years old - You are able to understand the study and participate for its full duration **You may NOT be eligible if...** - Your expected survival is less than 12 months - You have serious other conditions that significantly contribute to your lung high blood pressure - You are under 18 or over 80 years old - You are unable to follow study instructions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.