BPA vs. PEA in CTEPH

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.

Conditions

• Chronic Thromboembolic Pulmonary Hypertension

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.

Sponsors & Collaborators

• Kerckhoff Klinik

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• Papworth Hospital NHS Foundation Trust

  collaborator OTHER_GOV

• St. Antonius Hospital

  collaborator OTHER

• Utrecht University

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• Amsterdam UMC, location VUmc

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Irene Lang, MD,Prof · Medical University of Vienna

• Harm Jan Bogaard, MD, Prof. · Amsterdam University Medical Center

• Marion Delcroix, MD, Prof. · KU Leuven

• Marco Post, MD, Prof. · St. Antonius Hospital

• Gregely Meszaros, MD · Pulmonary Hypertension Association Europe

• Johanna Pepke-Zaba, MD, Prof. · Papworth Hospital NHS Foundation Trust

• Christoph Wiedenroth, MD · Kerckhoff Klinik

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2027-04-01

Completion

2028-04-01

Countries

• Denmark
• United Kingdom

Study Locations