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

Not yet recruiting

• Conditions: Acute Pulmonary Embolism

• Registration Number: NCT06819865
• Lead Sponsor: Boston Scientific Corporation

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.

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 Timeline

• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-05-30
• Study Start: 2025-06-30
• Primary Completion: 2027-03-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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	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	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	After enrollment to end of study，through study completion, an average of 1 year	All of SAE related to EKOS or procedure