Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2018-03-18
2020-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
OTHER
Study Groups
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Participants with intracranial large vessel occlusive stroke
50 patients who have been treated with the Asahi Chikai Black 18 neurovascular guidewire.
Asahi 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.
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.
No interventions assigned to this group
Interventions
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Asahi 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Asahi Intecc USA Inc
INDUSTRY
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Reade A De Leacy
Assistant Professor of Neurosurgery and Radiology; Director of Neurointerventional Spine
Principal Investigators
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Reade De Leacy, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Other Identifiers
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GCO 17-2723
Identifier Type: -
Identifier Source: org_study_id
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