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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

Tracking Information
First Submitted Date  ICMJE February 23, 2016
First Posted Date  ICMJE February 26, 2016
Results First Submitted Date  ICMJE April 2, 2021
Results First Posted Date  ICMJE April 29, 2021
Last Update Posted Date May 24, 2021
Study Start Date  ICMJE April 2016
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2021)
  • Change in RV/LV Ratio [ Time Frame: Baseline to 48 hours ]
    Change in RV/LV ratio from 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
  • Reduction in RV/LV ratio [ Time Frame: Baseline to 48 hours ]
  • Major Adverse Events [ Time Frame: Within 48 hours ]
    Device-related death, major bleeding, and treatment related AEs
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FlowTriever Pulmonary Embolectomy Clinical Study
Official Title  ICMJE FlowTriever Pulmonary Embolectomy Clinical Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Embolism
  • Acute Pulmonary Embolism
  • Submassive Pulmonary Embolism
  • Massive Pulmonary Embolism
Intervention  ICMJE Device: FlowTriever System
Study Arms  ICMJE Experimental: FlowTriever System
Intervention: Device: FlowTriever System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2017)
106
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2016)
150
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02692586
Other Study ID Numbers  ICMJE 15-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Inari Medical
Study Sponsor  ICMJE Inari Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kenneth Rosenfield, MD Massachusetts General Hospital
Study Chair: Victor Tapson, MD Cedars-Sinai Medical Center
PRS Account Inari Medical
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP