Cognition and Imaging With Tigertriever
COGNITIVE
COGNITIVE Study- Cognition and Imaging With Tigertriever
1 other identifier
observational
424
1 country
3
Brief Summary
The objective of the COGNITIVE Study is to evaluate whether successful reperfusion with Tigertriever is associated with cognitive benefit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2022
CompletedFirst Posted
Study publicly available on registry
September 8, 2022
CompletedStudy Start
First participant enrolled
October 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
May 16, 2025
March 1, 2025
2 years
September 4, 2022
May 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Association between successful reperfusion* and cognitive benefit**
\*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.
180 days post treatment
Eligibility Criteria
The COGNITIVE Study will include male or female subjects age 18-75 who present with LVO and treated with the Tigertriever as indicated per approved IFU.
You may qualify if:
- Patients admitted with large vessel occlusion (LVO) and treated with the Tigertriever, as indicated per the approved IFU.
- Tigertriever was used as the first line treatment in the target vessel.
- A signed informed consent.
- Age 18-75 years (inclusive).
- No known significant pre-stroke disability (pre-stroke mRS 0 or 1).
You may not qualify if:
- Use of any other IA recanalization device prior to the Tigertriever in the target vessel, including aspiration catheter.
- Evidence of acute brain hemorrhage on CT and/or MRI at admission.
- Prior hemorrhage, stroke, thrombolysis, and/or endovascular therapy in the last 3 months.
- Probable cerebral amyloid angiopathy.
- Pre-stroke diagnosed dementia and/or prescribed cholinesterase inhibitors.
- Pre-stroke diagnosed and/or currently treated major depression.
- Pre-stroke learning or intellectual disability.
- Anticipated inability to obtain 6-month follow-up assessments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rapid Medicallead
Study Sites (3)
University of California
Los Angeles, California, 90095, United States
Corewell Health Research Institute
Grand Rapids, Michigan, 49503, United States
Westchester Medical Center
New York, New York, 10595, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2022
First Posted
September 8, 2022
Study Start
October 28, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
May 16, 2025
Record last verified: 2025-03