Skip to main content
Back to Trials
NCT05273762NARecruiting

Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever

Northwell Health

Start Date

1/25/2022

Completion Date

7/25/2027

Summary

This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.

Detailed 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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

FlowTriever

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Pulmonary Embolism

Locations

Northern Westchester Hospital

Mount Kisco, New York 10549

United States

Lenox Hill Hospital

New York, New York 10075

United States