Evaluating cognitive benefits after stroke treatment with Tigertriever
COGNITIVE Study- Cognition and Imaging With Tigertriever
This study is testing if using the Tigertriever device to treat strokes helps improve thinking and memory in patients aged 18-75.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 424 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Rapid Medical Industry-sponsored |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT05531461 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess whether successful reperfusion using the Tigertriever device in patients with large vessel occlusion (LVO) leads to cognitive improvements. Patients aged 18-75 who have been treated with the Tigertriever as a first-line intervention will be included. The study will involve monitoring cognitive outcomes over a six-month follow-up period to determine any associations between the treatment and cognitive benefits. The research will help clarify the impact of this specific stroke intervention on cognitive recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have experienced a stroke due to large vessel occlusion and have no significant pre-stroke disabilities.
Not a fit: Patients with prior significant neurological conditions, such as dementia or major depression, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into improving cognitive outcomes for stroke patients treated with the Tigertriever.
How similar studies have performed: While there is ongoing research into cognitive outcomes post-stroke, this specific approach using the Tigertriever is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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. \-
Where this trial is running
Los Angeles, California and 2 other locations
- University of California — Los Angeles, California, United States (Recruiting)
- Corewell Health Research Institute — Grand Rapids, Michigan, United States (Recruiting)
- Westchester Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Walid Haddad, Dr.
- Email: walid@rapid-medical.com
- Phone: +972 72 2503331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.