NCT03438565|CompletedFDA Device
SURE 18 Registry -Asahi Chikai Black 18 in LVO Stroke
Safety and Utility Profile of the Asahi Chikai Black 18 neuRovascular guidewirE in Large Vessel Occlusive Stroke: SURE 18 Registry
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Safety and Utility Profile of the Asahi Chikai Black 18 neuRovascular guidewirE in Large Vessel Occlusive Stroke: SURE 18 Registry
Sponsor study identifier
observational
100
1 country
1
Study Start
March 18, 2018
Actual (reported)Primary Completion
February 1, 2020
Actual (reported)Study Completion
February 1, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 13, 2018
Actual (reported)February 19, 2018
Actual (reported)March 18, 2018
Actual (reported)February 1, 2020
Actual (reported)February 1, 2020
Actual (reported)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
Modified Rankin Scale (mRS)
90 days post procedure
Change in NIH Stroke Scale (NIHSS)
24 hours
Number of neurovascular guidewires required per case
Day 1
50 patients who have been treated with the 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Reade De Leacy, MD
Icahn School of Medicine at Mount Sinai
100 participants (actual enrollment reported by the registry).
First Submitted
February 13, 2018
First Posted
February 19, 2018
Study Start
March 18, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 1, 2020
Actual (reported)Study Completion
February 1, 2020
Actual (reported)Last Updated
March 10, 2020
Record last verified: 2020-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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