FlowTriever for Acute Massive Pulmonary Embolism (FLAME)
NCT ID: NCT04795167
Last Updated: 2025-04-30
Study Results
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View full resultsBasic Information
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COMPLETED
115 participants
OBSERVATIONAL
2021-03-16
2022-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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FlowTriever Arm
FlowTriever Arm subjects are defined as those subjects where FlowTriever is used as the Primary Treatment for pulmonary embolism.
No interventions assigned to this group
Context Arm
Subjects with high-risk pulmonary embolism who are treated with non-FlowTriever therapies.
No interventions assigned to this group
Prior Therapy Arm
Subjects presenting with low/intermediate-risk PE who received advanced therapy but subsequently progressed to high-risk PE in the same hospital setting/admission.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Inari Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Mitchell Silver, MD
Role: PRINCIPAL_INVESTIGATOR
OhioHealth Riverside
James Horowitz, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Medical Center
Locations
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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
Countries
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References
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Silver MJ, Gibson CM, Giri J, Khandhar S, Jaber W, Toma C, Mina B, Bowers T, Greenspon L, Kado H, Zlotnick DM, Chakravarthy M, DuCoffe AR, Butros P, Horowitz JM. Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study. Circ Cardiovasc Interv. 2023 Oct;16(10):e013406. doi: 10.1161/CIRCINTERVENTIONS.123.013406. Epub 2023 Oct 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study
Other Identifiers
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20-001
Identifier Type: -
Identifier Source: org_study_id
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