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)

未提供0 个研究点目标入组 60 人开始时间: 待定

适应症

试验速览

暂无简介。

•Age >=18 years and provision of written informed consent.
•Symptomatic disease, defined as a modified Medical Research Council (mMRC) dyspnea scale score of >=
•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.
•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)
•Considered technically suitable for balloon pulmonary angioplasty (BPA) by the treating physician.
•Able to undergo cardiopulmonary exercise testing (CPET).
•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.

发起方

未提供