Status:
UNKNOWN
Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Inari Medical
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 evide...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 25 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05273762
Start Date
January 25 2022
End Date
July 25 2024
Last Update
December 28 2023
Active Locations (2)
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1
Northern Westchester Hospital
Mount Kisco, New York, United States, 10549
2
Lenox Hill Hospital
New York, New York, United States, 10075