Safety and Efficacy of Balloon Pulmonary Angioplasty in China

Chinese Pulmonary Vascular Disease Research Group

Status: Enrolling

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Treatments: Procedure: Balloon pulmonary angioplasty

Study type: Observational

Funder types: Other

Identifiers

NCT04206852

BPA registry

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.