Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Inari Medical
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
Clareo Health | FlowTriever for Acute Massive Pulmonary Embolism (FLAME)
