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

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

Study Overview

• Status: Completed
• Conditions: PE - Pulmonary Embolism; PE - Pulmonary Thromboembolism

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

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

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

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	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..	From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, which ever comes first.

Collaborators and Investigators

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

Study record dates

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): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: thromboembolism; PE; pulmonary embolism; thrombectomy; FlowTriever; massive pulmonary embolism; high risk pulmonary embolism
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thromboembolism; Pulmonary Embolism
• 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