Michigan Initial Experience Using Tigertriever for Thrombectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHenry Ford Health System
About this trial
The purpose of this research study is to collect data about the effectiveness (i.e. how the device works) and safety (how safe it is to use such a device) of the Tigertriever in restoring blood flow by removing thrombus (or blood clot) from a large intracranial vessel (blood vessel in the brain) in patients experiencing ischemic stroke within 8 hours of symptom onset.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted with large vessel occlusion (LVO) and treated with the Tigertriever, as per the approved indication.
Tigertriever was used as the first line treatment in the target vessel.
A signed informed consent.
Age ≥ 18.
Disqualifiers
None
Trial population
The registry will include male or female subjects age \> 18 who present with LVO and are treated with the Tigertriever as per the approved indication.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Mechanical Thrombectomy
Procedure/SurgeryYou will be asked to provide medical history, take neurological exams in the form of questionnaires, and provide imaging data.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Thrombectomy Treated Patients1 intervention
Trial outcomes
Primary outcomes
1
Modified Rankin Scale
Percentage of participants with a modified Rankin Scale (mRS) score ≤2
Time frame
From enrollment to 90 days post treatment2
Primary Effectiveness Endpoint
Percentage of participants with a mTICI Score ≥IIb
Time frame
By the end of the thrombectomy procdure.3
Primary Effectiveness Endpoint - mTICI
Percentage of participants with a mTICI Score ≥IIb after the first pass
Time frame
From time of event to after the first thrombectomy pass.Sponsors and contacts
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Source ClinicalTrials.gov