SURE 18 Registry -Asahi Chikai Black 18 in LVO Stroke

Study Overview
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Brief Summary
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The objective of this study is to obtain post market data on the Asahi Chikai Black 18 neurovascular guidewire in the treatment of intracranial large vessel occlusive stroke. This will be compared to a historical control that will include the prior 50 consecutive patients fitting the same selection criteria.

Detailed Description
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This is a prospective registry collecting information on 50 patients treated with the ASAHI Chikai Black 18 microguidewire. Patients will undergo mechanical thrombectomy for acute large vessel occlusive stroke within the anterior circulation as is standard of care. Additionally, this study will have a retrospective portion which will examine 50 consecutive patients who meet inclusion/exclusion criteria treated for acute anterior circulation large vessel occlusive stroke prior to the initiation of the Sure -18 Registry. This retrospective cohort will be 50 consecutive mechanical thrombectomy cases performed using any neurovascular microguidewire other than the device under study (Asahi Chikai Black 18) at the same enrolling centers leading up to December 10, 2018.

Official Title
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Safety and Utility Profile of the Asahi Chikai Black 18 neuRovascular guidewirE in Large Vessel Occlusive Stroke: SURE 18 Registry

Conditions
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Occlusive Stroke

Intervention / Treatment
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* Device: Asahi Chikai Black 18 neurovascular guidewire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients presenting with acute anterior cerebral circulation large vessel occlusive stroke ASPECT score 5 or better Occlusion of the ICA terminus and M1 MCA Favorable CT perfusion with clinical/radiologic mismatch Last known well out to 24 hours Age limit >18 years Baseline mRS 0-3 Exclusion Criteria: Intracranial hemorrhage ASPECTS (Alberta stroke program early CT score) <5 Unfavorable CT perfusion Baseline mRS 4 or greater Large vessel occlusive stroke with tandem lesion of the cervical internal carotid artery or posterior circulation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with intracranial large vessel occlusive stroke<br>50 patients who have been treated with the Asahi Chikai Black 18 neurovascular guidewire. | Device: Asahi Chikai Black 18 neurovascular guidewire<br>* The Asahi Chikai Black 18 microguidewire employs a reverse tapered shaft with 0.018 tip and 0.014 proximal shaft, which provides additional support and tactile feedback.<br>|
| Historical Control Group<br>The historical control will include 50 retrospective consecutive patients (who fulfill inclusion and exclusion criteria) treated for acute anterior circulation large vessel occlusive stroke prior to the initiation of the Sure -18 registry. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clot engagement | Time from guide catheter placement within the target ICA to clot engagement | 30 days | 
| Number of device related serious adverse events | Safety profile as measured by number of Intra-procedural device related serious adverse events | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale (mRS) | 0 No symptoms at all No significant disability despite symptoms; able to carry out all usual duties and activities Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Moderate disability; requiring some help, but able to walk without assistance Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Severe disability; bedridden, incontinent and requiring constant nursing care and attention Dead | 90 days post procedure | 
| Change in NIH Stroke Scale (NIHSS) | The score for each ability is a number between 0 (normal functioning) to 4 (completely impaired). The NIHSS has 11 different items and the highest possible score is 42. The higher the score, the more impaired a stroke patient is. | 24 hours | 
| Number of neurovascular guidewires required per case |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asahi Chikai Black 18 Neurovascular Guidewire, Prospective, Retrospective