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

NCT04326777 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-05-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Li Xuyan

    lead OTHER

Principal Investigators

  • Yuanhua Yang, PhD · Beijing Chao Yang Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04326777 on ClinicalTrials.gov