Overview
This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.
Description
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.
Eligibility
INCLUSION CRITERIA
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
EXCLUSION CRITERIA
E1. Patients with active and severe COVID-19 infection (e.g. using ventilator, requiring hemodynamic support)
E2. Unable to anti-coagulate with heparin or alternative
E3. Known sensitivity to radiographic contrast agents that cannot be pre-treated
E4. Life expectancy \< 6 months
E5. Current participation in another study that may interfere with the patient's participation in this study.
E6. Inability to consent
E7. Patient is pregnant or plans to become pregnant within the next 6 months and/or currently breastfeeding.
E8. Subsegmental pulmonary embolism only
