The purpose of this research study is to collect data about the effectiveness (i.e. how the device works) and safety (how safe it is to use such a device) of the Tigertriever in restoring blood flow by removing thrombus (or blood clot) from a large intracranial vessel (blood vessel in the brain) in patients experiencing ischemic stroke within 8 hours of symptom onset.
You have been asked to take part in a research study because you have recently been admitted for large vessel occlusion (LVO) and are being treated by Tigertriever. The treatment is a standard of care (SOC), and if you agree to take part in this study, your participation will include an additional study visit after 3 months. Your study visit will take place at Henry Ford Hospital Neurology or respective collaborator. For some research studies, such as the one you are being asked to join, it is important that you do not learn the results of certain tests. Whether you intend it or not, sometimes learning this information may make you change your actions and behaviors in ways that could impact the outcome of the study.
Study Type
OBSERVATIONAL
Enrollment
150
You will be asked to provide medical history, take neurological exams in the form of questionnaires, and provide imaging data.
Henry Ford Hospital
Detroit, Michigan, United States
Modified Rankin Scale
Percentage of participants with a modified Rankin Scale (mRS) score ≤2
Time frame: From enrollment to 90 days post treatment
Primary Effectiveness Endpoint
Percentage of participants with a mTICI Score ≥IIb
Time frame: By the end of the thrombectomy procdure.
Primary Effectiveness Endpoint - mTICI
Percentage of participants with a mTICI Score ≥IIb after the first pass
Time frame: From time of event to after the first thrombectomy pass.
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