An interventional study of FlowTriever System and Standard of Care in Pulmonary Embolism and Pulmonary Thromboembolism, sponsored by Inari Medical. Recruiting at 34 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Inari Medical (part of Stryker) · Not applicable, Interventional, and Treatment
Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care
832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.
This study's planned enrollment of 200 is above the median of 174 across 429 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Inari Medical is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
First submitted before Inari Medical became part of Stryker.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: FlowTriever System
Procedure: Standard of Care
Mechanical thrombectomy for pulmonary embolism
Standard of care treatment for pulmonary embolism
Composite clinical endpoint of the following adjudicated events:
1. All-cause mortality 2. Cardiac arrest 3. Bailout to an alternative therapeutic strategy 4. Major bleeding 5. ECMO life support
Time frame: The earlier of initial hospital discharge or 7 days after randomization
All-cause mortality
Time frame: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit
Cardiac arrest
Time frame: At the earlier of initial hospital discharge or 7 days post randomization
Bailout to an alternative therapeutic strategy
Time frame: At the earlier of initial hospital discharge or 7 days post randomization
Major bleeding
Time frame: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit
ECMO life support
Time frame: 7 days post-randomization
PE-related mortality
Time frame: 3 months
All-cause and PE-related readmissions
Time frame: 30 days and 90 days
Days alive outside hospital
Time frame: 90 days
PE-related quality of life, by PEmb-QoL
Time frame: 3 months
General health-related quality of life, by EQ-5D-5L
Time frame: 3 months
Post-PE Impairment diagnosis
Time frame: 3 months
Change in the RV/LV diastolic diameter ratio (RV/LV) as measured by echocardiography from baseline
Time frame: 72 hours
Plan to share: No
Started Dec 2024 (actual). Primary completion is estimated for Nov 2027, 35 months after the start.
Of 150 interventional studies with no phase under Pulmonary Embolism, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 35 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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