An observational study in Occlusive Stroke, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by Icahn School of Medicine at Mount Sinai · Observational
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.
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.
Exclusion Criteria:
50 patients who have been treated with the Asahi Chikai Black 18 neurovascular guidewire.
Device: Asahi Chikai Black 18 neurovascular guidewire
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.
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.
Time to clot engagement
Time from guide catheter placement within the target ICA to clot engagement
Time frame: 30 days
Number of device related serious adverse events
Safety profile as measured by number of Intra-procedural device related serious adverse events
Time frame: Day 1
Modified Rankin Scale (mRS)
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
Time frame: 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.
Time frame: 24 hours
Number of neurovascular guidewires required per case
Time frame: Day 1
Plan to share: No
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai