Real-world use of the EkoSonic Endovascular System for acute pulmonary embolism in Chinese patients
Official title: EkoSonic Endovascular System in China RWS(ANTEATER)
Run by Boston Scientific Corporation · NCT06819865 · Data updated 2026-11-12
This study tests whether the EkoSonic Endovascular System is safe and effective for Chinese patients with acute pulmonary embolism in routine clinical care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | September 30, 2026 |
| Main results expected | May 30, 2028 |
| Study ends | May 30, 2029 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT06819865 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with acute symptomatic pulmonary embolism (<14 days) and right ventricle to left ventricle end-diastolic diameter ratio ≥1, for whom the investigator plans to use the EkoSonic Endovascular System with rt-PA.
✕Probably not a fit
Patients without these criteria or in whom the device is not used as planned may not see a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multi-center, single-arm observational study enrolling up to 60 patients in total to collect real-world outcomes of the EkoSonic Endovascular System used with rt-PA for acute PE. The trial observes safety and efficacy during standard clinical practice without randomization. Eligibility includes adults with acute symptomatic PE (less than 14 days) and specific echocardiographic criteria indicating right ventricular strain. Data will be collected from real-world use at The First Affiliated Hospital, Sun Yat-sen University in Guangzhou, sponsored by Boston Scientific. The study design emphasizes naturalistic outcomes rather than a controlled comparison.
Why it matters
Potential benefit: If successful, the approach could support safer, effective use of the EkoSonic System in selected Chinese patients with acute PE.
How similar studies have gone: Previous real-world and device-based PE studies have shown promise, but this specific Chinese real-world, single-arm observational approach is largely exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The first Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Cheng Hong, Doctor — The First Affiliated Hospital of Guangzhou Medical University
- Study coordinator: Guangqi Chang, Doctor
- Email: changgq@mail.sysu.edu.cn
- Phone: 020-87755766
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.