FlowTriever for Acute Massive Pulmonary Embolism (FLAME)
Completed
Conditions studied: PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism
In brief
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
Key facts
- Study ID
- NCT04795167
- Run by
- Inari Medical
- People needed
- 115
- Starts
- 2021-03-16
- Expected to finish
- 2022-12-19
- Last updated by the study team
- 2025-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >=18 years Treatment team determines pulmonary embolism is the cause of shock, and the PE is high-risk per the protocol definitions
You may not qualify if…
- Out of hospital cardiac arrest with Glasgow Coma Scale of ≤8
- Witnessed cardiac arrest with ongoing CPR >30 minutes
- Contraindication to anticoagulants, i.e. heparin or alternative
- Hematocrit <28%
- Platelets <25,000/μL
- INR >8
- Intracardiac thrombus and/or intracardiac clot in transit
- Known anaphylactic sensitivity to radiographic agents that cannot be pre-treated
- History of pulmonary hypertension with systolic pulmonary arterial pressure >70 mmHg
- Presence of chronic medical conditions with estimated < 90 days life expectancy per physician discretion (should not consider the current pulmonary embolism and its treatment)
- Current participation in another drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
- Patient is known to be COVID-19 positive at hospital admission (patient has active COVID-19)
Where it is running
- Emory University — Atlanta, Georgia, United States
- Beaumont Royal Oak — Royal Oak, Michigan, United States
- Ascension Providence Hospital — Southfield, Michigan, United States
- Gates Vascular Institute / SUNY Buffalo — Buffalo, New York, United States
- Lenox Hill Hospital / Northwell Health — New York, New York, United States
- OhioHealth Riverside — Columbus, Ohio, United States
- Penn Presbyterian/Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
- UPMC — Pittsburgh, Pennsylvania, United States
- Lankenau Medical Center / Pulmonology Associates — Wynnewood, Pennsylvania, United States
- Inova Fairfax — Falls Church, Virginia, United States
Full record on ClinicalTrials.gov
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