NCT05273762Unknown不适用
Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever: Efficacy and Safety
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 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
- •≥ 18 years of age
- •Clinical signs and symptoms of low-risk Intermediate pulmonary embolism defined per 2019 ESC Guidelines:
- •Only one of the following:
- •Presence of either RV strain or RV dilation on CT scan or Echo TTE
- •4th generation Troponin T > 0.01 ng/mL or 5th generation Troponin T >14 ng/L
- •Troponin I > 51.4 ng/L (Northwell reference laboratory)
- •sPESI score 0 or >1*
- •*Signs of RV dysfunction on Echo TTE or CTPA or elevated cardiac biomarker levels may be present, despite a calculation of sPESI
- •Echocardiogram, Computed Tomography Pulmonary Angiogram, or pulmonary angiographic evidence of proximal filing defect in at least one main, lobar, or segmental pulmonary artery with or without pulmonary infarction
- •Hemodynamically stable
排除标准
- •Patients with active and severe COVID-19 infection (e.g. using ventilator, requiring hemodynamic support)
- •Unable to anti-coagulate with heparin or alternative
- •Known sensitivity to radiographic contrast agents that cannot be pre-treated
- •Life expectancy < 6 months
- •Current participation in another study that may interfere with the patient's participation in this study.
- •Inability to consent
- •Patient is pregnant or plans to become pregnant within the next 6 months and/or currently breastfeeding.
- •Subsegmental pulmonary embolism only
研究组 & 干预措施
FlowTriever
Experimental
干预措施: FlowTriever (Device)
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)
- Echocardiogram Measurements: Change(Pre-procedure to 30-day and 6-month follow up)
研究者
研究点 (2)
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