Clinical Study of Balloon Pulmonary Angioplasty for Patients With Chronic Thromboembolic Pulmonary Hypertension

Li Xuyan

Status: Unknown

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Treatments: Procedure: Ballon pulmonary angioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04326777

2019-KE-377

Details and patient eligibility

About

Chronic thromboembolic pulmonary hypertension (CTEPH) is the fourth group of pulmonary hypertension (PH) according to clinical classification. Pulmonary endarterectomy（PEA) is the preferred treatment for patients with CTEPH, however, PEA has its limitations, it only applies to the thrombi in the main, lobar, or segmental pulmonary arteries for patients with CTEPH, and the postoperative residual PH is found to be of high percentage. With the development of interventional techniques, balloon pulmonary angioplasty (BPA) has been used to treat chronic thrombotic pulmonary hypertension (CTEPH) with favorable results and has been identified as an effective and safe treatment for technically inoperable CTEPH. Balloon pulmonary angioplasty (BPA) has been accepted as a therapeutic strategy in accordance with the 2015 ESC/ESR guidelines, especially for patients with technically inoperable, an unfavorable risk-to-benefit ratio of the PEA. This study was a single-center prospective study that collects 3 time points data (before BPA, after final BPA, and follow-up ) to verify long-term safety and efficacy of BPA, as well as comparing the efficacy with targeted medical therapy, evaluating the complications of BPA, the survival of patients, and the postoperative quality of life.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• technically inoperable for PEA in patients with CTEPH
• unfavorable risk/benefit ratio for PEA
• residual or recurrent PH after PEA
• aged over 18 years old

Exclusion criteria

• other groups of PH except for CTEPH
• severe renal insufficiency(eGFR<30ml/min·1.73mˆ2)
• severe infectious diseases
• severe hemorrhagic tendency
• severe anaphylaxis of contrast
• pregnancy and lactation
• expected survival time is less than half a year due to tumor or other disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Ballon pulmonary angioplasty

Other group

Description:

Ballon pulmonary angioplasty(BPA) is a stepwise procedure requiring several separate sessions. The interval of a series of BPA is one month. In a series of BPA, there are 2 sessions, which are repeated at a 2-week interval. BPA is performed primarily on one side of the lung in the first session, then after 2 weeks, performed on the other side of the lung. In each session, the fluoroscopy time or the amount contrast are less than 60min and 200ml, respectively.

Treatment:

Procedure: Ballon pulmonary angioplasty