Safety and Efficacy of Balloon Pulmonary Angioplasty in China
Recruiting · NCT04206852 · Observational (researchers observe without assigning treatment) · Lead sponsor: Chinese Pulmonary Vascular Disease Research Group
View the official record on ClinicalTrials.gov →Interventions studied
Balloon pulmonary angioplasty
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
2 locations listed.
- center of pulmonary vascular disease, Fuwai hospital - Beijing, China
- Chinese Academy of Medical Sciences Fuwai hospital - Beijing, China