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.
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 Type
OBSERVATIONAL
Enrollment
30
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).
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.
Time frame: after the completion of EKOS treatment 48 hours compared with the baseline
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.
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
Recurrent symptomatic 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
All of SAE related to EKOS or procedure
Time frame: After enrollment to end of study，through study completion, an average of 1 year
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