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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue | Contact | 010-85216440 | Taimin.yue@bsci.com | |
| Guangqi Chang, Doctor | Contact | 020-87755766 | changgq@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Guangqi Chang, Doctor | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
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| PE events after the completion of EKOS treatment | Recurrent symptomatic 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 | All of SAE related to EKOS or procedure | After enrollment to end of study，through study completion, an average of 1 year |