Chronic Thromboembolic Pulmonary HypertensionNCT04206852
Safety and Efficacy of Balloon Pulmonary Angioplasty in China
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Chinese Pulmonary Vascular Disease Research Group at 2 sites in China.
Trial summary
Balloon pulmonary angioplasty (BPA) is a potential treatment for patients with pulmonary artery stenosis, including non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH), takayasu arteritis and fibrosis mediastinitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Balloon pulmonary angioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 11 May 2018to 11 May 2065
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic thromboembolic pulmonary hypertension patients admitted in hospital.
Who may be able to join
- 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
Who cannot join
- Patients unwilling or unable to provide written consent for participation in the study.
- Impossible to follow up.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
center of pulmonary vascular disease, Fuwai hospital
Beijing, 100037
Zhihong Liu, doctor, 8601088396816, zhihongliufuwai@163.com
Zhihong Liu, MD,PhD
- Recruiting
Chinese Academy of Medical Sciences Fuwai hospital
Beijing, 100037
Zhao zhihui, MD, 8615810348817, 1250167892@qq.com
Yang Tao, MD, 8618610358576, tsmcyt@163.com
About this study
Balloon pulmonary angioplasty (BPA) is a potential treatment for patients with pulmonary artery stenosis, including non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH), takayasu arteritis and fibrosis mediastinitis.
The aim of this study was to evaluate the safety and efficacy of BPA in CTEPH and patients not amenable to pulmonary endarterectomy(PEA) or suffered from persistent CTEPH after PEA, , takayasu arteritis and fibrosis mediastinitis.
Read the 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.
- Being tested
- Balloon pulmonary angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon pulmonary angioplastyProcedure or surgery
Also called BPA
Balloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events of BPA procedure.
Surveillance of complications including: vessel injury, desaturation, cough, mild hemoptysis (<50ml), severe hemoptysis (>50ml), reperfusion pulmonary injury, death.
Measured: From initiation of BPA to 3-12 months after last session
Change of Pulmonary artery pressure in mmHg caused by series of BPA.
Pulmonary artery pressure in mmHg is obtained by right cardiac catheterization.
Measured: From initiation of BPA to 3-12 months after last session
Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA.
Pulmonary vascular resistance (PVR) in Wood U is obtained by right cardiac catheterization.
Measured: From initiation of BPA to 3-12 months after last session
Change of cardiac index (CI) in L/m^2 caused by series of BPA.
Cardiac index (CI) in L/m^2 is obtained by right cardiac catheterization.
Measured: From initiation of BPA to 3-12 months after last session
Change of World Health Organization (WHO) functional capacity classification caused by series of BPA.
World Health Organization is obtained from electronic medical records.
Measured: From initiation of BPA to 3-12 months after last session
Change of six minutes walk distance in meter caused by series of BPA.
World Health Organization is obtained from electronic medical records.
Measured: From initiation of BPA to 3-12 months after last session
Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA.
World Health Organization is obtained from electronic medical records.
Measured: From initiation of BPA to 3-12 months after last session
Change of Peak VO2/kg in ml/min/kg caused by series of BPA.
Peak VO2/kg in ml/min/kg is obtained by cardiopulmonary exercise test.
Measured: From initiation of BPA to 3-12 months after last session
Change of diffusing capacity for carbon monoxide caused by series of BPA.
diffusing capacity for carbon monoxide in % is obtained from pulmonary function test
Measured: From initiation of BPA to 3-12 months after last session
Change of fibroblast activation protein inhibitor expression after BPA
Change of fibroblast activation protein inhibitor expression after BPA
Measured: From initiation of BPA to 3-12 months after last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start11 May 2018
- Primary completion11 May 2065 (estimated)
- Study completion11 May 2065 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206852
- Sponsor's protocol ID
- BPA registry
- Status last verified
- Sep 2026
- First submitted
- 26 Oct 2019
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Balloon Pulmonary Angioplasty in China
- ClinicalTrials.gov ID
- NCT04206852
- Acronym / sponsor ID
- BPA registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research GroupUniversity, hospital or other
- Study start
- 11 May 2018 (actual)
- Primary completion
- 11 May 2065 (estimated)
- Study completion
- 11 May 2065 (estimated)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Balloon pulmonary angioplasty (BPA) is a potential treatment for patients with pulmonary artery stenosis, including non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH), takayasu arteritis and fibrosis mediastinitis.
The aim of this study was to evaluate the safety and efficacy of BPA in CTEPH and patients not amenable to pulmonary endarterectomy(PEA) or suffered from persistent CTEPH after PEA, , takayasu arteritis and fibrosis mediastinitis.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic thromboembolic pulmonary hypertension patients admitted in hospital.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients unwilling or unable to provide written consent for participation in the study.
- Impossible to follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon pulmonary angioplastyAlso: BPABalloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography. | Procedure or surgery | – |
Primary outcome
Incidence of Treatment-Emergent Adverse Events of BPA procedure.
Time frame: From initiation of BPA to 3-12 months after last session
Surveillance of complications including: vessel injury, desaturation, cough, mild hemoptysis (<50ml), severe hemoptysis (>50ml), reperfusion pulmonary injury, death.
Change of Pulmonary artery pressure in mmHg caused by series of BPA.
Time frame: From initiation of BPA to 3-12 months after last session
Pulmonary artery pressure in mmHg is obtained by right cardiac catheterization.
Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA.
Time frame: From initiation of BPA to 3-12 months after last session
Pulmonary vascular resistance (PVR) in Wood U is obtained by right cardiac catheterization.
Change of cardiac index (CI) in L/m^2 caused by series of BPA.
Time frame: From initiation of BPA to 3-12 months after last session
Cardiac index (CI) in L/m^2 is obtained by right cardiac catheterization.
Change of World Health Organization (WHO) functional capacity classification caused by series of BPA.
Time frame: From initiation of BPA to 3-12 months after last session
World Health Organization is obtained from electronic medical records.
Change of six minutes walk distance in meter caused by series of BPA.
Time frame: From initiation of BPA to 3-12 months after last session
World Health Organization is obtained from electronic medical records.
Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA.
Time frame: From initiation of BPA to 3-12 months after last session
World Health Organization is obtained from electronic medical records.
Change of Peak VO2/kg in ml/min/kg caused by series of BPA.
Time frame: From initiation of BPA to 3-12 months after last session
Peak VO2/kg in ml/min/kg is obtained by cardiopulmonary exercise test.
Change of diffusing capacity for carbon monoxide caused by series of BPA.
Time frame: From initiation of BPA to 3-12 months after last session
diffusing capacity for carbon monoxide in % is obtained from pulmonary function test
Change of fibroblast activation protein inhibitor expression after BPA
Time frame: From initiation of BPA to 3-12 months after last session
Change of fibroblast activation protein inhibitor expression after BPA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Chinese Pulmonary Vascular Disease Research Group at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhihong Liu, doctor (8601088396985, zhihongliufuwai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events of BPA procedure. (time frame: From initiation of BPA to 3-12 months after last session). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.