Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever

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

Detailed Description
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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.

Official Title
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Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever: Efficacy and Safety

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: FlowTriever


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FlowTriever<br> | Device: FlowTriever<br>* Mechanical thrombectomy for pulmonary embolism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mMRC dyspnea score from |  | Baseline (state at time of admission to hospital) to 30-day follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pulmonary Embolism Quality of Life Questionnaire (PEmbQOL) |  | Procedure to 30-day, 3-month, and 6-month follow up. | 
| 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. | 
| Echocardiogram Measurements: Change |  | Pre-procedure to 30-day and 6-month follow up | 
| Echocardiogram Measurements: Change |  | From pre-procedure echocardiogram compared to 30-day and compared to 6-month follow up | 
| ICU Length of Stay | Time spent in the Intensive Care Unit (ICU) for the length of the hospital visit. | 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 | 
| 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 | 
| Change in hemodynamic measurements |  | Before insertion of device during the procedure compared to 5 minutes after device is removed | 
| Site Complications |  | Length of index hospitalization, length median of 9.1 days per AHA journal | 
| Oxygen Requirement |  | Length of index hospitalization, length median of 9.1 days per AHA journal | 
| All-cause Mortality |  | 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 |