RecruitingNCT04206852

Safety and Efficacy of Balloon Pulmonary Angioplasty in China

Sponsor

Chinese Pulmonary Vascular Disease Research Group

Enrollment

200 participants

Start Date

May 11, 2018

Study Type

OBSERVATIONAL

Conditions

Chronic Thromboembolic Pulmonary Hypertension

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria2

Patients unwilling or unable to provide written consent for participation in the study.
Impossible to follow up.

Interventions

PROCEDUREBalloon 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.