Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever
ConditionPulmonary Embolism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwell Health
About this trial
This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
FlowTriever
DeviceMechanical thrombectomy for pulmonary embolism
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: FlowTrieverExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in mMRC dyspnea score from
Time frame
Baseline (state at time of admission to hospital) to 30-day follow-up.Secondary outcomes
1
Change in Pulmonary Embolism Quality of Life Questionnaire (PEmbQOL)
Time frame
Procedure to 30-day, 3-month, and 6-month follow up.2
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.3
Echocardiogram Measurements: Change
Time frame
Pre-procedure to 30-day and 6-month follow up4
Echocardiogram Measurements: Change
Time frame
From pre-procedure echocardiogram compared to 30-day and compared to 6-month follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwell Health
Lead sponsor
Inari Medical
Collaborator
Source ClinicalTrials.gov