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Recruiting Observational

Cognition and Imaging With Tigertriever

NCT05531461 · tracked via the Priya Life Science USA tracker
Sponsor
Rapid Medical
Phase
Observational
Started
2024-10-28
Last updated
2026-10-09

Condition(s) studied

Stroke

Study summary

The objective of the COGNITIVE Study is to evaluate whether successful reperfusion with Tigertriever is associated with cognitive benefit.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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. \-

Primary outcome measure(s)

  • 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.

Trial sites (6)

FacilityCityRegionStatus
University of California Los Angeles California Recruiting
University of California, Irvine Orange California Recruiting
Corewell Health Research Institute Grand Rapids Michigan Recruiting
Westchester Medical Center New York New York Recruiting
Montefiore Medical Center The University Hospital for Albert Einstein College of Medicine The Bronx New York Recruiting
The Hospital of the University of Pennsylvania Philadelphia Pennsylvania Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05531461 on ClinicalTrials.gov ↗ ← All trials in the USA