Stroke
Conditions
Brief summary
The objective of the COGNITIVE Study is to evaluate whether successful reperfusion with Tigertriever is associated with cognitive benefit.
Interventions
None listed
Sponsors
Rapid Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association between successful reperfusion* and cognitive benefit** | 180 days post treatment | \*successful reperfusion is defined as eTICI ≥2b50 with the Tigertriever device. * Cognitive benefit is defined as change in Montreal Cognitive Assessment (MoCA) of 1.5 Standard Deviations (SD) from 4 days post treatment (or discharge if earlier) and 180 days post treatment; or MoCA ≥26 at 180 days post treatment. |
Countries
United States
Contacts
CONTACTWalid Haddad, Dr.
Outcome results
None listed