Recruiting

Tigertriever

Sponsor:

Rapid Medical

Code:

NCT05531461

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Stroke

Study ID

NCT05531461

Start date

Oct 28, 2024

Status verified date

Aug, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

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Study Design

Enrollment

424 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of California

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Tateshima Satoshi, MD

Corewell Health Research Institute

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Paul Mazaris, MD

Westchester Medical Center

Recruiting

New York, New York, United States, 10595

Contacts

Principal Investigator:

Chirag Gandhi

More Information

Sponsor

Rapid Medical

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rapid Medical on 2026-08-12.