Status:
COMPLETED
FlowTriever for Acute Massive Pulmonary Embolism (FLAME)
Lead Sponsor:
Inari Medical
Conditions:
PE - Pulmonary Embolism
PE - Pulmonary Thromboembolism
Eligibility:
All Genders
18+ years
Brief Summary
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
Eligibility Criteria
Inclusion
- Age \>=18 years Treatment team determines pulmonary embolism is the cause of shock, and the PE is high-risk per the protocol definitions
Exclusion
- 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)
Key Trial Info
Start Date :
March 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 19 2022
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04795167
Start Date
March 16 2021
End Date
December 19 2022
Last Update
April 30 2025
Active Locations (11)
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1
Emory University
Atlanta, Georgia, United States, 30308
2
Beaumont Royal Oak
Royal Oak, Michigan, United States, 48073
3
Ascension Providence Hospital
Southfield, Michigan, United States, 48075
4
Gates Vascular Institute / SUNY Buffalo
Buffalo, New York, United States, 14203