NCT04326777

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

Balloon Pulmonary Angioplasty for Patients With Chronic Thromboembolic Pulmonary Hypertension: A Single-center, Prospective Long-term Follow-up Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Li Xuyan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Thromboembolic Pulmonary Hypertension

Interventions

Type	Name	Description
PROCEDURE	Ballon pulmonary angioplasty	Percutaneous vascular access for BPA is via the femoral vein using Seldinger technique. A 5Fr sheath is inserted into the vein, through which a 6Fr long introducer sheath is advanced into the pulmonary artery. Subsequently, a 6Fr guiding catheter is advanced into the pulmonary artery being treated. Generally, selective pulmonary angiography should be performed to evaluate lesion feature before BPA. Then a 0.014-inch guidewire is used to cross the lesion, a balloon catheter of an appropriate diameter is selected to dilate the lesion.

Timeline

• Start date: 2020-04-15
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2020-03-30
• Last updated: 2020-05-22

Locations

1 site across 1 country: China