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Recruiting NCT05273762

Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever

Conditions: Pulmonary Embolism

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Northwell Health

Location: Northern Westchester Hospital Mount Kisco New York

Summary

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

Eligibility 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05273762). StuddyBuddy aggregates publicly available trial information.