FlowTriever Pulmonary Embolectomy Clinical Study (FLARE)

April 28, 2021 updated by: Inari Medical
Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

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
    • Alabama
      • Auburn, Alabama, United States
        • East Alabama Heart & Vascular
      • Birmingham, Alabama, United States
        • St. Vincent's
    • California
      • Los Angeles, California, United States
        • Cedars-Sinai Medical Center
    • Florida
      • Orlando, Florida, United States
        • Florida Hospital
      • Pensacola, Florida, United States
        • Sacred Heart Hospital
      • Tampa, Florida, United States
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States
        • Emory University
    • Kentucky
      • Danville, Kentucky, United States
        • Ephraim McDowell Regional Medical Center
      • Louisville, Kentucky, United States
        • Baptist Health
    • Louisiana
      • Metairie, Louisiana, United States
        • East Jefferson General Hospital
    • New York
      • Manhasset, New York, United States
        • North Shore University Hospital
    • Ohio
      • Columbus, Ohio, United States
        • Ohio State University
      • Columbus, Ohio, United States
        • OhioHealth Riverside Methodist Hospital
    • Pennsylvania
      • Erie, Pennsylvania, United States
        • UPMC Hamot
      • Philadelphia, Pennsylvania, United States
        • Penn Presbyterian Medical Center
      • Pittsburgh, Pennsylvania, United States
        • UPMC
    • Texas
      • Houston, Texas, United States
        • Houston Methodist Hospital
    • West Virginia
      • Charleston, West Virginia, United States
        • Charleston Area Medical Center

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical signs, symptoms and presentation consistent with acute PE
  • PE symptom duration ≤ 14 days
  • CTA evidence of proximal PE
  • RV/LV ratio ≥ 0.9 without syncope
  • Systolic BP ≥ 90 mmHg
  • Stable heart rate <130 BPM prior to procedure
  • Patient deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment

Exclusion Criteria:

  • Thrombolytic use within 30 days of baseline CTA
  • Pulmonary hypertension with peak PAP > 70 mmHg by right heart catheterization
  • Vasopressor requirement after fluids to keep pressure ≥ 90 mm Hg
  • FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
  • Hematocrit < 28% within 6 hours of index procedure
  • Platelets < 100,000/µL
  • Serum creatinine > 1.8 mg/dL
  • INR > 3
  • Major trauma ISS > 15
  • Presence of intracardiac lead in right ventricle or atrium placed within 6 months
  • Cardiovascular or pulmonary surgery within last 7 days
  • Actively progressing cancer
  • Known bleeding diathesis or coagulation disorder
  • Left bundle branch block
  • History of severe or chronic pulmonary arterial hypertension
  • History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
  • History of uncompensated heart failure
  • History of underlying lung disease that is oxygen-dependent
  • History of chest irradiation
  • History of Heparin-induced thrombocytopenia
  • Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
  • Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
  • Imaging evidence or other evidence that suggests the subject is not appropriate for mechanical thrombectomy intervention
  • Life expectancy of < 90 days
  • Female who is pregnant or nursing
  • Current participation in another investigational drug or device treatment study

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FlowTriever System
Device: FlowTriever System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in RV/LV Ratio
Time Frame: Baseline to 48 hours
Change in RV/LV ratio from baseline to 48 hours
Baseline to 48 hours
Number of Participants With Major Adverse Events
Time Frame: Within 48 hours
Device-related death, major bleeding, and treatment related AEs
Within 48 hours

Collaborators and Investigators

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

Sponsor

Inari Medical

Investigators

  • Study Chair: Kenneth Rosenfield, MD, Massachusetts General Hospital
  • Study Chair: Victor Tapson, MD, Cedars-Sinai Medical Center

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

April 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

May 24, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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