Safety and Efficacy of Balloon Pulmonary Angioplasty in China
1 other identifier
observational
1,000
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2018
CompletedFirst Submitted
Initial submission to the registry
October 26, 2019
CompletedFirst Posted
Study publicly available on registry
December 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2065
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 11, 2065
September 24, 2026
September 1, 2026
47 years
October 26, 2019
September 21, 2026
Conditions
Outcome Measures
Primary Outcomes (10)
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.
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.
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.
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.
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.
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.
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.
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.
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
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
From initiation of BPA to 3-12 months after last session
Interventions
Balloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.
Eligibility Criteria
Chronic thromboembolic pulmonary hypertension patients admitted in hospital.
You may qualify if:
- 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
You may not qualify if:
- Patients unwilling or unable to provide written consent for participation in the study.
- Impossible to follow up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
center of pulmonary vascular disease, Fuwai hospital
Beijing, 100037, China
Chinese Academy of Medical Sciences Fuwai hospital
Beijing, 100037, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2019
First Posted
December 20, 2019
Study Start
May 11, 2018
Primary Completion (Estimated)
May 11, 2065
Study Completion (Estimated)
May 11, 2065
Last Updated
September 24, 2026
Record last verified: 2026-09