A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EkoSonicTM Endovascular System.
- Who it may be relevant to
- Registry conditions: Acute Pulmonary Embolism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
EkoSonic Endovascular System in China RWS(ANTEATER)
Overview
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.
Interventions
- Device 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).
Primary outcome measures
- RV vs LV end-diastolic diameter ratio [Time frame: after the completion of EKOS treatment 48 hours compared with the baseline]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
China · 1 center
- The first Affiliated Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT06819865 · S6364