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Recruiting NCT05531461

Cognition and Imaging With Tigertriever

Observational Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

COGNITIVE Study- Cognition and Imaging With Tigertriever

Overview

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

Primary outcome measures

  • Association between successful reperfusion* and cognitive benefit** [Time frame: 180 days post treatment]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 3 centers
  • University of California — Los Angeles
  • Corewell Health Research Institute — Grand Rapids
  • Westchester Medical Center — New York

Identifiers

NCT: NCT05531461 · COGNITIVE Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗