A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism
NCT ID: NCT06819865
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
30 participants
OBSERVATIONAL
2026-03-30
2028-07-30
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
EkoSonicTM Endovascular System
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).
Interventions
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EkoSonicTM Endovascular System
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).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Guangqi Chang, Doctor
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Central Contacts
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Other Identifiers
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S6364
Identifier Type: -
Identifier Source: org_study_id
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