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Safety and Efficacy of Balloon Pulmonary Angioplasty in China

Balloon pulmonary angioplasty (BPA) is a potential treatment for patients with pulmonary artery stenosis, including non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH), takayasu arteritis and fibrosis mediastinitis. The aim of this study was to evaluate the safety and efficacy of BPA in CTEPH and patients not amenable to pulmonary endarterectomy(PEA) or suffered from persistent CTEPH after PEA, , takayasu arteritis and fibrosis mediastinitis.

ClinicalTrials.gov IDNCT04206852

PhaseNot Applicable

Enrollment1000

SponsorChinese Pulmonary Vascular Disease Research Group

Age18 Years

SexALL

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Conditions studied

Chronic Thromboembolic Pulmonary Hypertension

About this study

Interventions

Procedure: Balloon pulmonary angioplasty — Balloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.

Primary outcomes

Incidence of Treatment-Emergent Adverse Events of BPA procedure. (From initiation of BPA to 3-12 months after last session)
Change of Pulmonary artery pressure in mmHg caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
Change of cardiac index (CI) in L/m^2 caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
Change of World Health Organization (WHO) functional capacity classification caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
Change of six minutes walk distance in meter caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
Change of Peak VO2/kg in ml/min/kg caused by series of BPA. (From initiation of BPA to 3-12 months after last session)

Eligibility information

Inclusion Criteria: 1. diagnosed with CTEPH according to ESC Guidelines (1) Mean PAP ≥ 25mmHg at rest; or if mean PAP \< 25mmHg at rest, have exercise limitations from chronic thromboembolic disease (2)Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines 2. Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH 3. Not amenable to pulmonary endarterectomy 4. Willing to provide informed consent Exclusion Criteria: 1. Patients unwilling or unable to provide written consent for participation in the study. 2. Impossible to follow up.

Study locations

center of pulmonary vascular disease, Fuwai hospital, Beijing, 100037 China
Chinese Academy of Medical Sciences Fuwai hospital, Beijing, 100037 China

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.