Cognition and Imaging With Tigertriever

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Association between successful reperfusion* and cognitive benefit**

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Walid Haddad, Dr.

CONTACT

[email protected]

+972 72 2503331

Sponsors and collaborators

Lead sponsor

Rapid Medical

Industry

Registry information

Official study title

COGNITIVE Study- Cognition and Imaging With Tigertriever

Acronym: COGNITIVE

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Sep 8, 2022
Registry last updated: May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting