Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever: Efficacy and Safety
This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.
⁃ I1. ≥ 18 years of age
⁃ I2. 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)
⁃ I3. 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 0.
⁃ I4. 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
⁃ I5. Hemodynamically stable