Safety and Efficacy of Balloon Pulmonary Angioplasty in China

Launched by CHINESE PULMONARY VASCULAR DISEASE RESEARCH GROUP · Dec 18, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Balloon Pulmonary Angioplasty (BPA) for patients with a condition known as Chronic Thromboembolic Pulmonary Hypertension (CTEPH). CTEPH is a serious lung problem caused by blood clots that block the blood vessels in the lungs, leading to high blood pressure in the lungs and difficulty breathing. The trial focuses on patients who are not suitable for a surgical procedure called pulmonary endarterectomy or those who still have CTEPH after having this surgery. The goal is to find out how safe and effective BPA is for these patients.

To participate in this trial, patients need to be diagnosed with CTEPH and have certain test results that confirm this diagnosis, along with having been on blood-thinning medication for at least three months. The trial is open to individuals aged 65 to 74, and both men and women can join. Participants will receive BPA treatment and will be monitored to ensure their safety and to assess how well the treatment works. It’s important that participants are willing to provide consent to take part in the study. If you or a loved one are interested in this trial, it could be a chance to explore a new treatment option for CTEPH.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. diagnosed with CTEPH according to ESC Guidelines (1) Mean PAP ≥ 25mmHg at rest; or if mean PAP \< 25mmHg at rest, have exercise limitations from chronic thromboembolic disease (2)Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
• • 2. Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
• • 3. Not amenable to pulmonary endarterectomy
• • 4. Willing to provide informed consent
• Exclusion Criteria:
• • 1. Patients unwilling or unable to provide written consent for participation in the study.
• • 2. Impossible to follow up.