SURE 18 Registry -Asahi Chikai Black 18 in LVO Stroke

Completed

• Conditions: Occlusive Stroke
• Interventions: Device: Asahi Chikai Black 18 neurovascular guidewire

• Registration Number: NCT03438565
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-19
• Study Start: 2018-03-18
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-07
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with intracranial large vessel occlusive stroke	Asahi Chikai Black 18 neurovascular guidewire	50 patients who have been treated with the Asahi Chikai Black 18 neurovascular guidewire.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
Number of neurovascular guidewires required per case	Day 1

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States