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

  • STATUS
    Recruiting
  • End date
    Apr 24, 2023
  • participants needed
    100
  • sponsor
    Li Xuyan
Updated on 3 March 2022
endarterectomy

Summary

Chronic thromboembolic pulmonary hypertension (CTEPH) is the fourth group of pulmonary hypertension (PH) according to clinical classification. Pulmonary endarterectomyPEA) 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.

Details
Condition Chronic Thromboembolic Pulmonary Hypertension
Treatment Ballon Pulmonary Angioplasty
Clinical Study IdentifierNCT04326777
SponsorLi Xuyan
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

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/min1.73m2)
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
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