A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism

NCT06819865 | Not Yet Recruiting FDA Device

• 1 other identifier: S6364
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Pulmonary Embolism

Keywords

PE

Outcome Measures

Primary Outcomes (1)

• 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.

  after the completion of EKOS treatment 48 hours compared with the baseline

Secondary Outcomes (3)

• RV vs LV end-diastolic diameter ratio

  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

  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

  After enrollment to end of study，through study completion, an average of 1 year

Study Arms (1)

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.

Device: EkoSonicTM Endovascular System

Interventions

EkoSonicTM Endovascular System DEVICE

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).

Single group observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Officials

• Guangqi Chang, Doctor

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue

CONTACT

010-85216440; Taimin.yue@bsci.com

Guangqi Chang, Doctor

CONTACT

020-87755766; changgq@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: February 11, 2025
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04