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| Name | Class |
|---|---|
| Asahi Intecc USA Inc | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with intracranial large vessel occlusive stroke | 50 patients who have been treated with the Asahi Chikai Black 18 neurovascular guidewire. |
| |
| Historical Control Group | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asahi Chikai Black 18 neurovascular guidewire | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) | 0 No symptoms at all
|
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Inclusion Criteria:
Exclusion Criteria:
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For the prospective portion, patients will be enrolled if their doctor decides to treat them with the ASAHI Chikai Black 18 Neurovascular Guidewire.
For the retrospective portion, 50 consecutive mechanical thrombectomy cases will be evaluated.
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| Name | Affiliation | Role |
|---|---|---|
| Reade De Leacy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| 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 |