Occlusive Stroke
Conditions
Keywords
Asahi Chikai Black 18 Neurovascular Guidewire, Prospective, Retrospective
Brief summary
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
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.
Interventions
DEVICEAsahi Chikai Black 18 neurovascular guidewire
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.
Sponsors
Asahi Intecc USA Inc
Icahn School of Medicine at Mount Sinai
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to clot engagement | 30 days | Time from guide catheter placement within the target ICA to clot engagement |
| Number of device related serious adverse events | Day 1 | Safety profile as measured by number of Intra-procedural device related serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) | 90 days post procedure | 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead |
| Change in NIH Stroke Scale (NIHSS) | 24 hours | 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. |
| Number of neurovascular guidewires required per case | Day 1 | — |
Countries
United States
Outcome results
None listed