Cognition and Imaging With Tigertriever

Stroke Clinical Trial

— COGNITIVE  

Official title:

COGNITIVE Study- Cognition and Imaging With Tigertriever

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05531461
• Other study ID #: COGNITIVE Study
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: November 2026

Study information

• Verified date: March 2023
• Source: Rapid Medical
• Contact: Walid Haddad, Dr.
• Phone: +972 72 2503331
• Email: walid[@]rapid-medical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 424
• Est. completion date: November 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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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Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rapid Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between successful reperfusion* and cognitive benefit**	*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.	180 days post treatment