FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
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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
PE - Pulmonary EmbolismPE - Pulmonary Thromboembolism
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients requiring thrombectomy treatment for pulmonary embolism.
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
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