A Multicenter, Open-label, Randomized Controlled Trial Comparing Balloon Pulmonary Angioplasty with Standard Medical Therapy in Patients with Chronic Thromboembolic Pulmonary Disease with Mean Pulmonary Artery Pressure Below 25 mmHg (BORDERLESS-CTEPD Trial) (BORDERLESS-CTEPD Trial)
A randomized study of balloon pulmonary angioplasty for chronic thromboembolic pulmonary disease with mean pulmonary artery pressure below 25 mmHg (BORDERLESS-CTEPD trial)
Satoh Taijyu
Tohoku University Graduate School of Medicine
1-1, seiryo-machi, Aoba-ku, Sendai
+81-227177153
taijyu.satoh.c6@tohoku.ac.jp
Satoh Taijyu
Tohoku University Graduate School of Medicine
1-1, seiryo-machi, aoba-ku, sendai, Miyagi
+81-227177153
taijyu.satoh.c6@tohoku.ac.jp
Pending
July. 01, 2026
60
Interventional
randomized controlled trial
open(masking not used)
no treatment control/standard of care control
parallel assignment
treatment purpose
1. Age >=18 years and provision of written informed consent.
2. Symptomatic disease, defined as a modified Medical Research Council (mMRC) dyspnea scale score of >=1.
3. Imaging-confirmed chronic thromboembolic pulmonary disease (CTEPD), defined by at least one of the following:
- Organized thrombi, webs, bands, or mosaic perfusion patterns identified on computed tomography pulmonary angiography (CTPA) or catheter-based pulmonary angiography (PAG); or
- Persistent mismatched perfusion defects on ventilation-perfusion (V/Q) scintigraphy or single-photon emission computed tomography (SPECT).
These findings must be confirmed after at least 3 months of therapeutic anticoagulation.
4. Right heart catheterization performed within 180 days prior to initiation of the study intervention, demonstrating:
- Mean pulmonary artery pressure (mPAP) <25 mmHg
- Pulmonary artery wedge pressure (PAWP) <=15 mmHg
- Measurable cardiac output (CO)
5. Considered technically suitable for balloon pulmonary angioplasty (BPA) by the treating physician.
6. Able to undergo cardiopulmonary exercise testing (CPET).
7. Able to complete the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36).
1.Presence of respiratory disease requiring active treatment.
2.Presence of orthopedic or musculoskeletal disorders that significantly limit exercise capacity.
3.Ongoing anticancer therapy that has been initiated or modified within the previous 6 months, or for which modification is planned during the study period.
4.Estimated life expectancy of less than 1 year.
5.Systolic systemic blood pressure <80 mmHg.
6.Clinically significant left heart disease, defined as left ventricular ejection fraction (LVEF) <40%.
7.Severe renal dysfunction (creatinine clearance <15 mL/min) or hepatic dysfunction (AST or ALT >2 times the upper limit of normal).
8.Predominantly central thromboembolic lesions considered suitable for pulmonary endarterectomy (PEA) as the first-line treatment.
9.Current treatment with pulmonary vasodilators for pulmonary hypertension (use for connective tissue disease is permitted).
10.Pregnancy or breastfeeding.
11.Previous treatment with balloon pulmonary angioplasty (BPA) or pulmonary endarterectomy (PEA).
12.Any condition that, in the opinion of the principal investigator, would make participation in the study inappropriate.
18age 0month 0week old over
No limit
Both
Chronic thromboembolic pulmonary disease (CTEPD) with mean pulmonary artery pressure below 25 mmHg
Intervention: Balloon Pulmonary Angioplasty (BPA) Group
Participants allocated to the BPA group will undergo balloon pulmonary angioplasty (BPA) after randomization. Because BPA is performed in addition to standard medical therapy, all standard supportive treatments that were being administered before randomization will be continued throughout the study.
Following the initial BPA session, a 3-month BPA treatment period will be established, during which 2 to 6 BPA sessions will be performed as clinically indicated. Because the pulmonary vascular bed contains numerous target vessels in both lungs and the treatment area achievable during a single BPA session is limited, at least two BPA sessions are planned to ensure a minimum treatment extent and procedural standardization.
A 1-month allowance period will be permitted within the BPA treatment period; therefore, the planned BPA treatment course should be completed within 4 months of the initial BPA procedure.
Although a minimum of two BPA sessions is recommended, early completion of BPA treatment is permitted at the discretion of the treating physician if a sufficient therapeutic effect has been achieved or if further procedures are deemed inappropriate because of complications or other clinical considerations.
The final study assessment will be performed after an interval of at least 2 months following the last BPA session and will be scheduled to coincide with the 6-month follow-up visit (Day 168) after the initial BPA procedure.
Periprocedural management and anticoagulation therapy during BPA will be conducted according to the standard practice of each participating institution. Anticoagulation therapy will be continued throughout the study period.
BPA
Change in peak oxygen uptake (peak VO2; mL/kg/min) measured by cardiopulmonary exercise testing (CPET) from baseline to 6 months after enrollment.
Change in SF-36 score from baseline to 6 months after enrollment.
Change in 6-minute walk distance, hemodynamic parameters, and oxygenation during the 6-minute walk test from baseline to 6 months after enrollment.
Change in pulmonary vascular resistance (PVR) measured by right heart catheterization at rest from baseline to 6 months after enrollment.
Change in World Health Organization functional class (WHO-FC) from baseline to 6 months after enrollment.
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels from baseline to 6 months after enrollment.
Change in the mPAP/CO slope from baseline to 6 months after enrollment.
Hospitalization for the development or worsening of heart failure or pulmonary hypertension, and all-cause mortality during follow-up after enrollment.
none
Clinical Research Ethics Committee, Tohoku University Hospital
