At a glance
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FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
In Brief
An observational study evaluating FlowTriever System and Anticoagulation Agents for PE - Pulmonary Embolism and PE - Pulmonary Thromboembolism. Completed, enrolled 1,200 participants across 81 sites in 9 countries.
Detailed 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. Up to 300 additional patients with anticoagulation treatment as the initial planned primary treatment strategy for intermediate risk PE will also be evaluated (US only).
Study Details
Timeline
Interventions
Thrombectomy
Anticoagulation medication