StrokeCOGNITIVENCT05531461
Cognition and Imaging With Tigertriever
An observational study of Stroke, run by Rapid Medical at 6 sites in United States.
Trial summary
The objective of the COGNITIVE Study is to evaluate whether successful reperfusion with Tigertriever is associated with cognitive benefit. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- How many people
- 424 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 Oct 2024to Nov 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients admitted with large vessel occlusion (LVO) and treated with the Tigertriever, as indicated per the approved IFU.
- Tigertriever was used as the first line treatment in the target vessel.
- A signed informed consent.
- Age 18-75 years (inclusive).
- No known significant pre-stroke disability (pre-stroke mRS 0 or 1).
Who cannot join
- Use of any other IA recanalization device prior to the Tigertriever in the target vessel, including aspiration catheter.
- Evidence of acute brain hemorrhage on CT and/or MRI at admission.
- Prior hemorrhage, stroke, thrombolysis, and/or endovascular therapy in the last 3 months.
- Probable cerebral amyloid angiopathy.
- Pre-stroke diagnosed dementia and/or prescribed cholinesterase inhibitors.
- Pre-stroke diagnosed and/or currently treated major depression.
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- Pre-stroke learning or intellectual disability.
- Anticipated inability to obtain 6-month follow-up assessments.
- -
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Corewell Health Research Institute
Grand Rapids, Michigan, 49503
Stephanie Mueller, 616-267-1072, Stephanie.Mueller@corewellhealth.org
Paul Mazaris, MD
- Recruiting
University of California
Los Angeles, California, 90095
Saima Chaabane, 310-794-4482, SChaabane@mednet.ucla.edu
Tateshima Satoshi, MD
- Recruiting
Westchester Medical Center
New York, New York, 10595
Cristina Falo, 914-493-8194, cristina.falo@wmchealth.org
Chirag Gandhi
- Recruiting
University of California, Irvine
Orange, California, 92868
Elizabeth Salcedo-Rodriguez, 949-824-9320, esalced1@hs.uci.edu
Shuichi Suzuki, MD Suzuki, MD
- Recruiting
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Leah Coghlan, 215-341-5864, Leah.Coghlan@pennmedicine.upenn.edu
Shish Srinivasan, MD
- Recruiting
Montefiore Medical Center The University Hospital for Albert Einstein College of Medicine
The Bronx, New York, 10467
Genesis Liriano, 718-920-2469, gliriano@montefiore.org
David Altschul, MD
About this study
Official title: 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.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start28 Oct 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 424 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Rapid Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531461
- Sponsor's protocol ID
- COGNITIVE Study
- Acronym
- COGNITIVE
- Status last verified
- Aug 2026
- First submitted
- 4 Sep 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COGNITIVE Study- Cognition and Imaging With Tigertriever
- ClinicalTrials.gov ID
- NCT05531461
- Acronym / sponsor ID
- COGNITIVE / COGNITIVE Study
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- Rapid MedicalIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the COGNITIVE Study is to evaluate whether successful reperfusion with Tigertriever is associated with cognitive benefit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Patients admitted with large vessel occlusion (LVO) and treated with the Tigertriever, as indicated per the approved IFU.
- Tigertriever was used as the first line treatment in the target vessel.
- A signed informed consent.
- Age 18-75 years (inclusive).
- No known significant pre-stroke disability (pre-stroke mRS 0 or 1).
Key exclusion criteria (9 listed)
- Use of any other IA recanalization device prior to the Tigertriever in the target vessel, including aspiration catheter.
- Evidence of acute brain hemorrhage on CT and/or MRI at admission.
- Prior hemorrhage, stroke, thrombolysis, and/or endovascular therapy in the last 3 months.
- Probable cerebral amyloid angiopathy.
- Pre-stroke diagnosed dementia and/or prescribed cholinesterase inhibitors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between successful reperfusion* and cognitive benefit**
Time frame: 180 days post treatment
*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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Rapid Medical at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walid Haddad, Dr. (+972 72 2503331, walid@rapid-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between successful reperfusion* and cognitive benefit** (time frame: 180 days post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.