FLASH study
Research type
Research Study
Full title
FLowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
IRAS ID
312642
Contact name
Mohammed Rashid Akhtar
Contact email
Sponsor organisation
Inari Medical Europe GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
The FlowTriever Retrieval/Aspiration System (referred to as “FlowTriever”) is CE-Marked, and thus commercially available in Europe. The FlowTriever is a device designed to treat pulmonary embolism (PE) in the lung by removing blood clots from blood vessels. The FlowTriever is used to trap the clot and pull it into a catheter so that the clot can be removed from the body. The purpose of the study is to collect information about how the FlowTriever works when treating PE and to collect data about the PE treatment. To participate in the study, a participant must be at least 18 years old and diagnosed with a PE. The study will be conducted in up to 70 sites in the US and up to 30 in Europe, of which a maximum of 3 sites in the UK. Data from the participant will be collected prior to treatment with the FlowTriever(≤ 48 hrs), at the time of treatment (Day 0), 48 hours (± 36 hrs), 30 days (± 15 days), and 6 months (± 90 days) after treatment.
Results Summary
The FLASH Registry (protocol number 18-002) has been sponsored by Inari Medical. The device under investigation is the sponsor’s FlowTriever device. This device is especially designed to remove blood clots from the pulmonary (lung) arteries for patients suffering from acute pulmonary embolism (PE) commonly known as blood clots. The most important question we wanted to answer is whether the device is safe to use and whether it is effective (does it work?). To answer this question 1000 adult patients participated in the study; 800 US patients and 200 European patients from Austria, Belgium, France, Germany, Spain, Switzerland and the UK. All these patients suffered from a potentially life-threatening blood clot in their pulmonary arteries and decided to help answering the questions above.
The patients underwent standard of care hospital tests prior to the actual removal of the blood clot (done with the FlowTriever device) and after the procedure. The only assessments which were not standard of care after the procedure were the 6-minute walk test and the questionnaires of life. These were done to evaluate how the patient was doing after the removal of the blood clot and if he/she was doing better and this up to 6 months after the removal of the blood clot.
This FLASH registry showed that, up to 48 hours after the removal of the blood clot, only 2.4% of the patients had very serious health problems and only 0.6% of the patients died but this due to different kinds of reasons (so not necessarily related to the blood clot removal).
At 30 days after the procedure 1.8% of the patients died due to different kinds of reasons again not necessarily related to the blood clot removal. Only 1 patient died during the procedure. None of the patients who died, died because of the FlowTriever device. No serious health problems which happened to the patients for up to 30 days following the procedure were because of the Flowtriever device.
In addition, the study showed that immediate improvement in hemodynamics (= blood pressure, not only in your arteries but also in the chambers of your heart) were noticed immediately after the procedure and it showed that the patients themselves reported a generally better health status 6 months after the procedure.
All the above suggests that a (fast) removal of the blood clot in the pulmonary arteries, with the sponsor’s FlowTriever device, is safe to use for immediate relief hemodynamically and may prevent or reduce long term health problems for patients who have suffered from pulmonary blood clots.
The sponsor’s future plans are to further investigate the FlowTriever device by comparing it to other similar devices or medical treatments, which are commercially on the market already, and evaluate how FlowTriever performs compared to these.
More information about the FLASH Registry and its results can be found on clinicaltrials.gov (with reference NCT03761173).REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
22/NW/0125
Date of REC Opinion
31 May 2022
REC opinion
Further Information Favourable Opinion