NCT05273762招募中不适用
Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever: Efficacy and Safety
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Change in mMRC dyspnea score from
研究概览
简要总结
This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.
详细描述
In this study, patients that present with low-risk submassive pulmonary embolism with hemodynamic stability and with either positivity of cardiac biomarkers, or radiographic or echocardiographic evidence of right ventricular strain will be assigned to be treated with mechanical thrombectomy, which includes conscious sedation, via FlowTriever.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in mMRC dyspnea score from
时间窗: Baseline (state at time of admission to hospital) to 30-day follow-up.
次要结局
- Echocardiogram Measurements: Change(From pre-procedure echocardiogram compared to 30-day and compared to 6-month follow up)
- Device related death Device related bleeding Device related vascular injury Device related cardiac injury Clinical deterioration Rescue intervention(From end of index hospitalization to 30 days post-procedure, whichever comes first)
- Oxygen Requirement(Length of index hospitalization, length median of 9.1 days per AHA journal)
- Bleeding Re-thrombosis Edema Pain(From end of index hospitalization to 30 days post-procedure, whichever comes first)
- Change in Six Minute Walk Test (6MWT) (distance covered in meters over 6 minutes)(Pre-procedure to 30-day, 3-month, and 6-month follow up.)
- Change in hemodynamic measurements(Before insertion of device during the procedure compared to 5 minutes after device is removed)
- All-cause Mortality(Length of index hospitalization, length median of 9.1 days per AHA journal)
- Change in Pulmonary Embolism Quality of Life Questionnaire (PEmbQOL)(Procedure to 30-day, 3-month, and 6-month follow up.)
- ICU Length of Stay(Length of index hospitalization, length of hospitalization median of 9.1 days, length of ICU stay median 3.1 per JNS)
- Hospital Duration(Length of index hospitalization, length median of 9.1 days per AHA journal)
- Site Complications(Length of index hospitalization, length median of 9.1 days per AHA journal)
研究者
研究点 (3)
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