The first Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Location status: Recruiting
Recruiting
NCT Number: NCT06819865
A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
This is a multi-center, single arm, prospective, observational, real-world study.To collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care.
Up to 30 patients will be enrolled in this study and up to 30 patients will be enrolled in this study to observation safety and efficacy.
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- The patients with acute symptomatic pulmonary embolism (Symptomatic duration < 14 days).
- The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image
- Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.
Exclusion criteria
- The patients with acute symptomatic pulmonary embolism (Symptomatic duration < 14 days).
- The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image
- Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.
Treatment and study plan
EkoSonicTM Endovascular System
DeviceEkoSonicTM 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).
Primary outcomes
-
RV vs LV end-diastolic diameter ratio
Time frame: 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.
Secondary outcomes
-
RV vs LV end-diastolic diameter ratio
Time frame: after the completion of EKOS treatment 24 hours, Discharge(Approximately within 15 days after completed treatment) , after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline，through study completion, an average of 1 year
The change in the right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio at 24h, Discharge(Approximately within 15 days after completed treatment) , after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline.
-
PE events after the completion of EKOS treatment
Time frame: After the completion of EKOS treatment 24hours, 48hours,Discharge(Approximately within 15 days after completed treatment), after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline
Recurrent symptomatic PE events after the completion of EKOS treatment.
-
Serious adverse events related to EKOS or procedure
Time frame: After enrollment to end of study，through study completion, an average of 1 year
All of SAE related to EKOS or procedure
Study contacts
Contact information is provided by the study sponsor or research team.
Cheng Hong, Doctor
CONTACT
Guangqi Chang, Doctor
CONTACT
Sponsors and collaborators
Lead sponsor
Boston Scientific Corporation
Industry
Registry information
Official study title
EkoSonic Endovascular System in China RWS(ANTEATER)
Acronym: ANTEATER
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Feb 11, 2025
- Registry last updated
- Jul 21, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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