Safety and Efficacy of Balloon Pulmonary Angioplasty in China
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese Pulmonary Vascular Disease Research Group
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients unwilling or unable to provide written consent for participation in the study.
Impossible to follow up.
Trial population
Chronic thromboembolic pulmonary hypertension patients admitted in hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Balloon pulmonary angioplasty
Procedure/SurgeryBalloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
From initiation of BPA to 3-12 months after last session2
Change of Pulmonary artery pressure in mmHg caused by series of BPA.
Pulmonary artery pressure in mmHg is obtained by right cardiac catheterization.
Time frame
From initiation of BPA to 3-12 months after last session3
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.
Time frame
From initiation of BPA to 3-12 months after last session4
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.
Time frame
From initiation of BPA to 3-12 months after last sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov