Acute Pulmonary EmbolismANTEATERNCT06819865
A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism
An observational study of Acute Pulmonary Embolism, run by Boston Scientific Corporation at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pulmonary Embolism
- What is being tested?
- EkoSonicTM Endovascular System
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 30 May 2029
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: This study will enroll patients who received EkoSonicTM Endovascular System treatment with r-tPA for acute pulmonary thromboembolism, and who could provide sufficient echocardiographic quality to assess the collection of primary endpoint, and prospectively collect the clinical data related to the protocol in the actual clinical diagnosis and treatment
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The first Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Cheng Hong, Doctor, 020-81568636, gyfyyhc@126.com
About this study
Official title: EkoSonic Endovascular System in China RWS(ANTEATER)
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.
Read the detailed description
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.
- Conditions
- Acute Pulmonary Embolism
- Being tested
- EkoSonicTM Endovascular System
- Keywords
- PE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EkoSonicTM Endovascular SystemDevice
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 group | Role | What they receive |
|---|---|---|
| Single group observational study | To collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care. Receives: Device: EkoSonicTM Endovascular System |
What is being measured
The primary outcome is the main question the study is designed to answer.
RV vs LV end-diastolic diameter ratio
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.
Measured: after the completion of EKOS treatment 48 hours compared with the baseline
Secondary outcomes (3)
RV vs LV end-diastolic diameter ratio
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.
Measured: 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
PE events after the completion of EKOS treatment
Recurrent symptomatic PE events after the completion of EKOS treatment.
Measured: 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
Serious adverse events related to EKOS or procedure
All of SAE related to EKOS or procedure
Measured: After enrollment to end of study，through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start30 Sep 2026
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheng Hong, Doctor, Principal investigator, The First Affiliated Hospital of Guangzhou Medical UniversityGuangqi Chang, Doctor, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819865
- Sponsor's protocol ID
- S6364
- Acronym
- ANTEATER
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EkoSonic Endovascular System in China RWS(ANTEATER)
- ClinicalTrials.gov ID
- NCT06819865
- Acronym / sponsor ID
- ANTEATER / S6364
- Conditions
- Acute Pulmonary Embolism
- Keywords
- PE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group observational study | – | Device: EkoSonicTM Endovascular SystemTo collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will enroll patients who received EkoSonicTM Endovascular System treatment with r-tPA for acute pulmonary thromboembolism, and who could provide sufficient echocardiographic quality to assess the collection of primary endpoint, and prospectively collect the clinical data related to the protocol in the actual clinical diagnosis and treatment
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EkoSonicTM Endovascular SystemEkoSonicTM 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). | Device | Single group observational study |
Primary outcome
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.
3 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
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
Serious adverse events related to EKOS or procedure
Time frame: After enrollment to end of study，through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Related trials for Acute Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
Not yet recruitingPhase 3
Reduced-Dose Thrombolysis in Intermediate-Risk Pulmonary Embolism With High-Risk Features
Pulmonary Embolism
Not yet recruiting
Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism
Acute Pulmonary Embolism
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheng Hong, Doctor principal investigator
The First Affiliated Hospital of Guangzhou Medical University
Guangqi Chang, Doctor principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pulmonary Embolism, run by Boston Scientific Corporation at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guangqi Chang, Doctor (020-87755766, changgq@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RV vs LV end-diastolic diameter ratio (time frame: after the completion of EKOS treatment 48 hours compared with the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.