Prospective, multi-center, open-label, single-arm clinical study of the safety and effectiveness of the eTrieve™ in subjects presenting with signs and symptoms of acute intermediate-risk pulmonary embolism
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Patients will be treated with the eTrieve PE Kit
MAE
Number of Major Adverse Event (MAE) within 48 hours post-index procedure, as adjudicated by the Clinical Events Committee (CEC)
Time frame: 48 hours
RV/LV ratio
Change in RV/LV ratio from baseline to 48 hours post-index procedure (or discharge, whichever occurs first) as assessed by the CTA core laboratory
Time frame: 48 hours
Use of thrombolytics
Use of thrombolytics within 48 hours post-index procedure
Time frame: within 48 hours
ICU/hospitalization length
Length of stay in the Intensive Care Unit (ICU)/hospital, associated with the index thrombectomy procedure
Time frame: within 30 days
Modified Miller score
Change in the Modified Miller Score between baseline and 48 hours post-index procedure as assessed by the CTA core laboratory
Time frame: at 48 hours
Mortality
Mortality due to any cause within 30 days post-index procedure
Time frame: within 30 days
Device related SAE
Device-related serious adverse events within 30 days post-index procedure, as adjudicated by the CEC
Time frame: within 30 days
PE reocurrence
Symptomatic PE recurrence within 30 days post-index procedure
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Time frame: within 30 days