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FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)

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: NCT03761173
Recruitment Status : Enrolling by invitation
First Posted : December 3, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Inari Medical

Study Description
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Brief Summary:
To 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 (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice.

Condition or disease Intervention/treatment
PE - Pulmonary Embolism PE - Pulmonary Thromboembolism Device: FlowTriever System

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: FlowTriever All-Comer Registry for Patient Safety and Hemodynamics
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

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Groups and Cohorts
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Intervention Details:
  • Device: FlowTriever System
    Thrombectomy

Outcome Measures
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Primary Outcome Measures :
  1. Composite Major Adverse Events [ Time Frame: 48-hours ]
    Rate of subjects with composite of device-related death, major bleeding, device or procedure-related adverse events


Secondary Outcome Measures :
  1. Individual Major Adverse Events [ Time Frame: 48-hours ]
    Rate of subjects with individual components of composite MAE

  2. All-cause mortality [ Time Frame: 30-days ]
    Rate of deaths

  3. Device-related serious adverse events [ Time Frame: 30-days ]
    Rate of device-related SAEs


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring thrombectomy treatment for pulmonary embolism.
Criteria

Inclusion Criteria:

  • Clinical signs and symptoms consistent with acute PE
  • CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery
  • Scheduled for PE treatment with the FlowTriever System per the Investigator's discretion

Exclusion Criteria:

  • Unable to be anticoagulated with heparin or alternative
  • Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
  • Imaging evidence or other evidence that suggests, in the Investigator's opinion, the subject is not appropriate for mechanical thrombectomy intervention
  • Life expectancy < 30 days, as determined by Investigator
  • Current participation in another investigational drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
Contacts and Locations
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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): NCT03761173


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30308
Longstreet Clinic
Gainesville, Georgia, United States, 30506
United States, Kentucky
Louisville Cardiology Group
Louisville, Kentucky, United States, 40207
United States, Minnesota
Metropolitan Heart and Vascular Institute
Coon Rapids, Minnesota, United States, 55433
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, United States, 56303
United States, Missouri
Saint Luke's Cardiovascular Consultants
Lee's Summit, Missouri, United States, 64086
United States, Pennsylvania
UPMC Heart & Vascular Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Inari Medical
More Information
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Additional Information:

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Responsible Party: Inari Medical
ClinicalTrials.gov Identifier: NCT03761173     History of Changes
Other Study ID Numbers: 18-002
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inari Medical:
PE
pulmonary embolism
thromboembolism
thrombectomy
FlowTriever
Additional relevant MeSH terms:
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Pulmonary Embolism
Thromboembolism
Embolism
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases