This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Mechanical thrombectomy for pulmonary embolism
Northern Westchester Hospital
Mount Kisco, New York, United States
ENROLLING_BY_INVITATIONLenox Hill Hospital
New York, New York, United States
RECRUITINGChange in mMRC dyspnea score from
Time frame: Baseline (state at time of admission to hospital) to 30-day follow-up.
Change in Pulmonary Embolism Quality of Life Questionnaire (PEmbQOL)
Time frame: 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)
Time frame: Pre-procedure to 30-day, 3-month, and 6-month follow up.
Echocardiogram Measurements: Change
Time frame: Pre-procedure to 30-day and 6-month follow up
Echocardiogram Measurements: Change
Time frame: 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.
Time frame: Length of index hospitalization, length of hospitalization median of 9.1 days, length of ICU stay median 3.1 per JNS
Hospital Duration
Time frame: 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
Time frame: From end of index hospitalization to 30 days post-procedure, whichever comes first
Change in hemodynamic measurements
Time frame: Before insertion of device during the procedure compared to 5 minutes after device is removed
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Site Complications
Time frame: Length of index hospitalization, length median of 9.1 days per AHA journal
Oxygen Requirement
Time frame: Length of index hospitalization, length median of 9.1 days per AHA journal
All-cause Mortality
Time frame: Length of index hospitalization, length median of 9.1 days per AHA journal
Bleeding Re-thrombosis Edema Pain
Time frame: From end of index hospitalization to 30 days post-procedure, whichever comes first