NCT04206852

Safety and Efficacy of Balloon Pulmonary Angioplasty in China

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Chinese Pulmonary Vascular Disease Research Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Chronic Thromboembolic Pulmonary Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-11
• Primary completion: 2028-05-11
• Completion: 2028-05-11
• First posted: 2019-12-20
• Last updated: 2023-12-20

Locations

2 sites across 1 country: China