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

April 28, 2025 updated by: Inari Medical
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Royal Oak
      • Southfield, Michigan, United States, 48075
        • Ascension Providence Hospital
    • New York
      • Buffalo, New York, United States, 14203
        • Gates Vascular Institute / SUNY Buffalo
      • New York, New York, United States, 10075
        • Lenox Hill Hospital / Northwell Health
    • Ohio
      • Columbus, Ohio, United States, 43214
        • OhioHealth Riverside
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian/Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Wynnewood, Pennsylvania, United States, 19076
        • Lankenau Medical Center / Pulmonology Associates
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with high-risk (massive) pulmonary embolism.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
FlowTriever Arm
FlowTriever Arm subjects are defined as those subjects where FlowTriever is used as the Primary Treatment for pulmonary embolism.
Context Arm
Subjects with high-risk pulmonary embolism who are treated with non-FlowTriever therapies.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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, whichever comes first.

The primary endpoint is the in-hospital composite endpoint of all-cause mortality, bailout to an alternative thrombus removal strategy, clinical deterioration, and major bleeding (BARC 3b/3c/5a/5b definition). The primary endpoint was assessed in the FlowTriever Arm compared to a pre-specified performance goal of 32%.

Subjects in the Context Arm were analyzed separately using descriptive methods. The primary endpoint in the Context Arm was not compared to a performance goal. Data collection for Prior Therapy Arm subjects included information surrounding the PE treatment, progression to High-Risk PE, and patient course through hospital discharge. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.
From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Incidence of mortality
From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Bailout to an Alternative Thrombus Removal Strategy
Time Frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Incidence of bailout to an alternative thrombus removal strategy
From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Clinical Deterioration
Time Frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Incidence of clinical deterioration
From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Major Bleeding
Time Frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Incidence of major bleeding
From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Frequency of Stroke
Time Frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Incidence of ischemic or hemorrhagic stroke
From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Device-related Complications
Time Frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Incidence of device-related complications
From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Access Site Injury Requiring Intervention, Both Venous and Arterial
Time Frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Incidence of access site injury requiring intervention, including both venous and arterial
From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Length of post-treatment hospital stay, measured in number of overnights
From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Length of ICU Stay
Time Frame: From treatment start or ICU admission, whichever is later, to ICU discharge
Length of post-treatment ICU stay, measure in number of overnights
From treatment start or ICU admission, whichever is later, to ICU discharge
Use of ECMO
Time Frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Frequency of ECMO use, including either pre or post treatment initiation
From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Discharge Location
Time Frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Discharge location after hospital stay
From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Time to Extubation
Time Frame: From the time of initiation of primary treatment to extubation
Time to extubation reported as number of days
From the time of initiation of primary treatment to extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inari Medical

Investigators

  • Principal Investigator: Mitchell Silver, MD, OhioHealth Riverside
  • Principal Investigator: James Horowitz, MD, NYU Langone Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2021

Primary Completion (Actual)

December 19, 2022

Study Completion (Actual)

December 19, 2022

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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