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FlowTriever Pulmonary Embolectomy Clinical Study (FLARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02692586
Recruitment Status : Completed
First Posted : February 26, 2016
Results First Posted : April 29, 2021
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
Inari Medical

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: FlowTriever System Device: FlowTriever System


Outcome Measures
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Primary Outcome Measures :
  1. Change in RV/LV Ratio [ Time Frame: Baseline to 48 hours ]
    Change in RV/LV ratio from baseline to 48 hours

  2. Number of Participants With Major Adverse Events [ Time Frame: Within 48 hours ]
    Device-related death, major bleeding, and treatment related AEs


Eligibility Criteria
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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 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
Contacts and Locations
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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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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
  Study Documents (Full-Text)

Documents provided by Inari Medical:
Study Protocol and Statistical Analysis Plan  [PDF] June 30, 2016

More Information
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Responsible Party: Inari Medical
ClinicalTrials.gov Identifier: NCT02692586    
Other Study ID Numbers: 15-001
First Posted: February 26, 2016    Key Record Dates
Results First Posted: April 29, 2021
Last Update Posted: May 24, 2021
Last Verified: April 2021
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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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases