FlowTriever for Acute Massive Pulmonary Embolism (FLAME)

Launched by INARI MEDICAL · Mar 10, 2021

Keywords

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ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>=18 years Treatment team determines pulmonary embolism is the cause of shock, and the PE is high-risk per the protocol definitions
• Exclusion Criteria:
• • 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)