Cognition and Imaging With Tigertriever (COGNITIVE)

Rapid Medical

Status: Enrolling

Conditions: Stroke

Study type: Observational

Funder types: Industry

Identifiers

NCT05531461

COGNITIVE Study

Details and patient eligibility

About

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

Enrollment: 424 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.