Safety and Efficacy of Balloon Pulmonary Angioplasty in China

Study Overview
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Brief Summary
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Balloon pulmonary angioplasty (BPA) is a potential treatment for non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH). The aim of this study was to evaluate the safety and efficacy of BPA in CTEPH patients not amenable to pulmonary endarterectomy(PEA) or suffered from persistent CTEPH after PEA.

Detailed Description
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This study is a prospective, multi-center, long-term observational project to study the safety and efficacy of BPA. Clinical evaluation, including: functional capacity, 6-minutes walking test, biomarkers, cardiopulmonary exercise test, electrocardiography, echocardiography, haemodynamics, pulmonary angiography and lung scintigraphy was performed before the initiation therapy of BPA, and 3-12 months after last session of BPA. we also aim to evaluate the value of FAPI in predicting the efficacy and the prognosis of patients with CTEPH who received BPA.

Official Title
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Safety and Efficacy of Balloon Pulmonary Angioplasty in China

Conditions
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Chronic Thromboembolic Pulmonary Hypertension

Intervention / Treatment
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* Procedure: Balloon pulmonary angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH Not amenable to pulmonary endarterectomy Willing to provide informed consent Exclusion Criteria: Patients unwilling or unable to provide written consent for participation in the study. Impossible to follow up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events of BPA procedure. | Surveillance of complications including: vessel injury, desaturation, cough, mild hemoptysis (<50ml), severe hemoptysis (>50ml), reperfusion pulmonary injury, death. | From initiation of BPA to 3-12 months after last session | 
| Change of Pulmonary artery pressure in mmHg caused by series of BPA. | Pulmonary artery pressure in mmHg is obtained by right cardiac catheterization. | 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. | Pulmonary vascular resistance (PVR) in Wood U is obtained by right cardiac catheterization. | 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. | Cardiac index (CI) in L/m^2 is obtained by right cardiac catheterization. | 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. | World Health Organization is obtained from electronic medical records. | From initiation of BPA to 3-12 months after last session | 
| Change of six minutes walk distance in meter caused by series of BPA. | World Health Organization is obtained from electronic medical records. | 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. | World Health Organization is obtained from electronic medical records. | 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. | Peak VO2/kg in ml/min/kg is obtained by cardiopulmonary exercise test. | From initiation of BPA to 3-12 months after last session | 
| Change of diffusing capacity for carbon monoxide caused by series of BPA. | diffusing capacity for carbon monoxide in % is obtained from pulmonary function test | From initiation of BPA to 3-12 months after last session | 
| Change of fibroblast activation protein inhibitor expression after BPA | Change of fibroblast activation protein inhibitor expression after BPA | From initiation of BPA to 3-12 months after last session |