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Recruiting
NCT05531461
Cognition and Imaging With Tigertriever
Conditions: Stroke
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 424
Sponsor: Rapid Medical
Location: University of California Los Angeles California
Summary
The objective of the COGNITIVE Study is to evaluate whether successful reperfusion with Tigertriever is associated with cognitive benefit.
Eligibility Criteria
Inclusion Criteria:
1. Patients admitted with large vessel occlusion (LVO) and treated with the Tigertriever, as indicated per the approved IFU.
2. Tigertriever was used as the first line treatment in the target vessel.
3. A signed informed consent.
4. Age 18-75 years (inclusive).
5. No known significant pre-stroke disability (pre-stroke mRS 0 or 1).
Exclusion Criteria:
1. Use of any other IA recanalization device prior to the Tigertriever in the target vessel, including aspiration catheter.
2. Evidence of acute brain hemorrhage on CT and/or MRI at admission.
3. Prior hemorrhage, stroke, thrombolysis, and/or endovascular therapy in the last 3 months.
4. Probable cerebral amyloid angiopathy.
5. Pre-stroke diagnosed dementia and/or prescribed cholinesterase inhibitors.
6. Pre-stroke diagnosed and/or currently treated major depression.
7. Pre-stroke learning or intellectual disability.
8. Anticipated inability to obtain 6-month follow-up assessments.
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Source: ClinicalTrials.gov (NCT05531461). StuddyBuddy aggregates publicly available trial information.