Cognition and Imaging With Tigertriever (COGNITIVE)

COGNITIVE Study- Cognition and Imaging With Tigertriever

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

Study Overview

• Status: Recruiting
• Conditions: Stroke

• Study Type: Observational
• Enrollment (Estimated): 424

Contacts and Locations

• Study Contact: Name: Walid Haddad, Dr.; Phone Number: +972 72 2503331; Email: walid@rapid-medical.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California
      • Contact: Saima Chaabane; Phone Number: 310-794-4482; Email: SChaabane@mednet.ucla.edu
      • Principal Investigator: Tateshima Satoshi, MD
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Corewell Health Research Institute
      • Contact: Stephanie Mueller; Phone Number: 616-267-1072; Email: Stephanie.Mueller@corewellhealth.org
      • Principal Investigator: Paul Mazaris, MD
  • New York
    • New York, New York, United States, 10595
      • Recruiting
      • Westchester Medical Center
      • Contact: Cristina Falo; Phone Number: 914-493-8194; Email: cristina.falo@wmchealth.org
      • Principal Investigator: Chirag Gandhi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The COGNITIVE Study will include male or female subjects age 18-75 who present with LVO and treated with the Tigertriever as indicated per approved IFU.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rapid Medical

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: September 4, 2022
• First Submitted That Met QC Criteria: September 4, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: COGNITIVE Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No