EkoSonicTM Endovascular System: EkoSonicTM Endovascular System and its upgraded versions if applicable The EkoSonicTM Endovascular System is a non-implanted system comprising a sterile, single-use EkoSonic Endovascular Device (Infusion Catheter and Ultrasonic Core) and reusable EKOSTM Control System 4.0(Control Unit, Connector Interface Cable and power cord).
Study summary
This study to collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. The patients with acute symptomatic pulmonary embolism (Symptomatic duration \< 14 days).
2. The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image
3. Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.
Exclusion Criteria:
1. The patients with acute symptomatic pulmonary embolism (Symptomatic duration \< 14 days).
2. The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image
3. Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.
Primary outcome measure(s)
RV vs LV end-diastolic diameter ratio — after the completion of EKOS treatment 48 hours compared with the baseline The change in the right ventricular end-diastolic diameter to left ventricle end-diastolic diameter ratio at 48hours after the completion of EKOS treatment compared with the baseline.
Trial sites (1)
Facility
City
Region
Status
The first Affiliated Hospital, Sun Yat-sen University
Guangzhou
Guangdong
Recruiting
More Boston Scientific Corporation trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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