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FLowTriever for Acute Massive Pulmonary Embolism (FLAME) (FLAME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04795167
Recruitment Status : Enrolling by invitation
First Posted : March 12, 2021
Last Update Posted : June 4, 2021
Sponsor:
Information provided by (Responsible Party):
Inari Medical

Brief Summary:
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism

Condition or disease
PE - Pulmonary Embolism PE - Pulmonary Thromboembolism

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FLowTriever for Acute Massive Pulmonary Embolism (FLAME)
Actual Study Start Date : March 16, 2021
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
FlowTriever Arm
Context Arm
Prior Therapy Arm



Primary Outcome Measures :
  1. Composite incidence of all-cause mortality, clinical deterioration, bailout, and major bleeding [ Time Frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, which ever comes first. ]
    Endpoint events will be assessed from the time of treatment of the high-risk pulmonary embolism through hospital discharge for the high-risk PE, or through 45 days post treatment for high-risk pulmonary embolism, whichever comes first..



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with high-risk (massive) pulmonary embolism.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795167


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30308
United States, Michigan
Beaumont Royal Oak
Royal Oak, Michigan, United States, 48073
Ascension Providence Hospital
Southfield, Michigan, United States, 48075
United States, New York
Gates Vascular Institute / SUNY Buffalo
Buffalo, New York, United States, 14203
Lenox Hill Hospital / Northwell Health
New York, New York, United States, 10075
United States, Ohio
OhioHealth Riverside
Columbus, Ohio, United States, 43214
United States, Pennsylvania
Penn Presbyterian/Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Lankenau Medical Center / Pulmonology Associates
Wynnewood, Pennsylvania, United States, 19076
United States, Virginia
Inova Fairfax
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Inari Medical
Investigators
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Principal Investigator: Mitchell Silver, MD OhioHealth Riverside
Principal Investigator: James Horowitz, MD NYU Langone Medical Center
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Responsible Party: Inari Medical
ClinicalTrials.gov Identifier: NCT04795167    
Other Study ID Numbers: 20-001
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inari Medical:
PE
pulmonary embolism
thromboembolism
thrombectomy
FlowTriever
massive pulmonary embolism
high risk pulmonary embolism
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases