The FLASH registry study is a prospective, single-arm, multicenter analysis of the FlowTriever system in moderate (submassive) and severe (massive) LE. The registry will collect data on demographics, comorbidities, details of LE diagnosis and treatment, and clinical outcomes up to 6-month follow-up.
Aim of the study
The primary objective of the study is to evaluate the safety and efficacy of the FlowTriever system for the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism. The use of the device is evaluated in a real-world population, with approval criteria that closely resemble its use in clinical practice.
Who can take part?
Adult patients with acute pulmonary embolism
Procedure
FLASH aims to assess the safety and efficacy of the FlowTriever system in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device is evaluated in a realistic patient population that closely resembles its use in everyday clinical practice. At the Clinic for Angiology in Zurich, only high-risk patients (hemodynamically unstable) with acute LE are included.
Original study name
FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
BASEC number
2021-02164