Cognition and Imaging With Tigertriever
ConditionStroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorRapid Medical
About this trial
The objective of the COGNITIVE Study is to evaluate whether successful reperfusion with Tigertriever is associated with cognitive benefit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
180 days post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov