EkoSonic Endovascular System in China RWS(ANTEATER)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- RV vs LV end-diastolic diameter ratio
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: EkoSonicTM Endovascular System (Device)
结局指标
主要结局
RV vs LV end-diastolic diameter ratio
时间窗: 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.
次要结局
- 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)
- 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(After enrollment to end of study，through study completion, an average of 1 year)