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FlowTriever Pulmonary Embolectomy Clinical Study (FLARE)

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ClinicalTrials.gov Identifier: NCT02692586
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Inari Medical

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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Acute Pulmonary Embolism Submassive Pulmonary Embolism Massive Pulmonary Embolism Device: FlowTriever System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FlowTriever Pulmonary Embolectomy Clinical Study
Study Start Date : April 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Arm Intervention/treatment
Experimental: FlowTriever System Device: FlowTriever System



Primary Outcome Measures :
  1. Reduction in RV/LV ratio [ Time Frame: Baseline to 48 hours ]
  2. Major adverse events [ Time Frame: Within 48 hours ]
    Device-related death, major bleeding, and treatment related AEs



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 catheterizatoin
  • Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
  • 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 HIT
  • 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

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): NCT02692586


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

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Responsible Party: Inari Medical
ClinicalTrials.gov Identifier: NCT02692586     History of Changes
Other Study ID Numbers: 15-001
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Inari Medical:
Thromboembolism
Thrombectomy
Right Heart Strain
Submassive PE
Right Ventricle Dysfunction
Massive PE

Additional relevant MeSH terms:
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Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases