Acute Pulmonary Embolism
Conditions
Keywords
PE
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.
Interventions
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).
Sponsors
Boston Scientific Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
CONTACTGuangqi Chang, Doctor
CONTACTCheng Hong, Doctor
PRINCIPAL_INVESTIGATORCheng Hong, Doctor
The First Affiliated Hospital of Guangzhou Medical University
PRINCIPAL_INVESTIGATORGuangqi Chang, Doctor
First Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed