Evaluating balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension in China
Official title: Safety and Efficacy of Balloon Pulmonary Angioplasty in China
Run by Chinese Pulmonary Vascular Disease Research Group · NCT04206852 · Data updated 2026-11-12
This study is testing whether balloon pulmonary angioplasty can safely help people with chronic thromboembolic pulmonary hypertension who can't have surgery or still have symptoms after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Chinese Pulmonary Vascular Disease Research Group Academic / other |
| Locations | 2 sites (Beijing and 1 other locations) |
| Status | Recruiting |
| Started | May 11, 2018 |
| Main results expected | May 11, 2065 |
| Study ends | May 11, 2065 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT04206852 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with CTEPH who are not amenable to pulmonary endarterectomy and have been on anticoagulation therapy for at least three months.
✕Probably not a fit
Patients who are unwilling or unable to provide consent or those who cannot be followed up will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the safety and efficacy of balloon pulmonary angioplasty (BPA) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not suitable for pulmonary endarterectomy or have persistent CTEPH after the procedure. The study involves a multi-center approach, where clinical evaluations such as functional capacity tests, biomarkers, and imaging studies will be conducted before and after BPA treatment. Additionally, the study will explore the predictive value of FAPI in determining treatment efficacy and patient prognosis.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with CTEPH who currently have limited therapeutic alternatives.
How similar studies have gone: While balloon pulmonary angioplasty is a recognized treatment, this specific observational study is novel in its comprehensive evaluation of safety and efficacy in the Chinese population.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
center of pulmonary vascular disease, Fuwai hospital
Beijing, China Recruiting -
Chinese Academy of Medical Sciences Fuwai hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Zhihong Liu, doctor
- Email: zhihongliufuwai@163.com
- Phone: 8601088396985
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How pulmonary endarterectomy affects confidence in managing chronic thromboembolic pulmonary hypertension
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Registry of people with chronic thromboembolic pulmonary hypertension in Russia
This registry collects health, history, and treatment information from people in Russia with chronic thromboembolic pulmonary hypertension to see which factors relate to their prognosis.
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Effects of stopping riociguat on heart function in patients with CTEPH
This study is testing how stopping the medication riociguat affects heart function in patients with inoperable CTEPH who have had balloon pulmonary angioplasty.
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Switching from Sildenafil to Riociguat for CTEPH Patients
This study is testing if switching from sildenafil to riociguat can help people with Chronic Thromboembolic Pulmonary Hypertension feel better after they’ve already had balloon pulmonary angioplasty.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.