Safety and Efficacy of Balloon Pulmonary Angioplasty in China

N/ARecruitingNCT04206852

Chinese Pulmonary Vascular Disease Research Group200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Interventions

Balloon pulmonary angioplastyPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

center of pulmonary vascular disease, Fuwai hospital

Beijing, China

RECRUITING

Chinese Academy of Medical Sciences Fuwai hospital

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

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.