Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever

Northwell Health

Status: Enrolling

Conditions: Pulmonary Embolism

Treatments: Device: FlowTriever

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05273762

21-1117

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

FlowTriever

Experimental group

Treatment:

Device: FlowTriever