Millipede 088 Post-Marketing Study
Research type
Research Study
Full title
Post Marketing Study to Evaluate Millipede 088 Effectiveness for Clot Retrieval in Acute Ischemic Stroke.
IRAS ID
309110
Contact name
Hazel Kilkelly
Contact email
Sponsor organisation
Perfuze Ltd
Duration of Study in the UK
1 years, 1 months, 28 days
Research summary
This study is being conducted to gather information about a medical device used for treating patients that are having a stroke. The device being assessed in this study is called the Millipede 088. It is a tube, called a catheter, that sucks clots from the brain in patients that are having a stroke. The study is being carried out to assess how effectively and safely the device removes clots from the blood vessels in the brain.
This device has received CE mark approval, meaning it meets the safety and performance requirements of the relevant European legislation. Millipede 088 medical device is currently available for market use in the European Union (EU), European Economic Area (EEA) and the United Kingdom (UK).
Up to 100 subjects may be recruited at up to 8 investigation sites across the UK and Germany. Subject follow-ups will be conducted at Day 0, 24 hours post-procedure, Day 7 post-procedure or hospital discharge/transfer (whichever occurs soonest) if performed per institutional standard practice and Day 90 post-procedure. An mRS assessment may be conducted with the participant by a member of the research team at 90 days post-procedure if this assessment has not been completed as part of the participants standard of care. The mRS assessment will be conducted via telephone to minimize the burden on the participant. Apart from the mRS assessment at 90 days post-procedure, all other data collected as part of this post-market clinical follow-up study is collected as part of the participant's standard of care, and there are no further study specific assessments to be completed by participants.
REC name
Wales REC 1
REC reference
22/WA/0059
Date of REC Opinion
14 Apr 2022
REC opinion
Further Information Favourable Opinion