search
Back to results

FlowTriever Pulmonary Embolectomy Clinical Study (FLARE)

Primary Purpose

Pulmonary Embolism, Acute Pulmonary Embolism, Submassive Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FlowTriever System
Sponsored by
Inari Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Thromboembolism, Thrombectomy, Right Heart Strain, Submassive PE, Right Ventricle Dysfunction, Massive PE

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • East Alabama Heart & Vascular
  • St. Vincent's
  • Cedars-Sinai Medical Center
  • Florida Hospital
  • Sacred Heart Hospital
  • Tampa General Hospital
  • Emory University
  • Ephraim McDowell Regional Medical Center
  • Baptist Health
  • East Jefferson General Hospital
  • North Shore University Hospital
  • Ohio State University
  • OhioHealth Riverside Methodist Hospital
  • UPMC Hamot
  • Penn Presbyterian Medical Center
  • UPMC
  • Houston Methodist Hospital
  • Charleston Area Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FlowTriever System

Arm Description

Outcomes

Primary Outcome Measures

Change in RV/LV Ratio
Change in RV/LV ratio from baseline to 48 hours
Number of Participants With Major Adverse Events
Device-related death, major bleeding, and treatment related AEs

Secondary Outcome Measures

Full Information

First Posted
February 23, 2016
Last Updated
April 28, 2021
Sponsor
Inari Medical
search

1. Study Identification

Unique Protocol Identification Number
NCT02692586
Brief Title
FlowTriever Pulmonary Embolectomy Clinical Study
Acronym
FLARE
Official Title
FlowTriever Pulmonary Embolectomy Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inari Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Acute Pulmonary Embolism, Submassive Pulmonary Embolism, Massive Pulmonary Embolism
Keywords
Thromboembolism, Thrombectomy, Right Heart Strain, Submassive PE, Right Ventricle Dysfunction, Massive PE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FlowTriever System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
FlowTriever System
Primary Outcome Measure Information:
Title
Change in RV/LV Ratio
Description
Change in RV/LV ratio from baseline to 48 hours
Time Frame
Baseline to 48 hours
Title
Number of Participants With Major Adverse Events
Description
Device-related death, major bleeding, and treatment related AEs
Time Frame
Within 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Rosenfield, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Victor Tapson, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
East Alabama Heart & Vascular
City
Auburn
State/Province
Alabama
Country
United States
Facility Name
St. Vincent's
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Sacred Heart Hospital
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Ephraim McDowell Regional Medical Center
City
Danville
State/Province
Kentucky
Country
United States
Facility Name
Baptist Health
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
East Jefferson General Hospital
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
OhioHealth Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
UPMC Hamot
City
Erie
State/Province
Pennsylvania
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
UPMC
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
Country
United States
Facility Name
Charleston Area Medical Center
City
Charleston
State/Province
West Virginia
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

FlowTriever Pulmonary Embolectomy Clinical Study

We'll reach out to this number within 24 hrs