Clinical trial NCT03438565: SURE 18 Registry -Asahi Chikai Black 18 in LVO Stroke
Official title: Safety and Utility Profile of the Asahi Chikai Black 18 neuRovascular guidewirE in Large Vessel Occlusive Stroke: SURE 18 Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Occlusive Stroke
Keywords: Asahi Chikai Black 18 Neurovascular Guidewire
Prospective
Retrospective
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Asahi Intecc USA Inc
First posted: 2018-02-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Time to clot engagement
timeFrame: 30 days
measure: Number of device related serious adverse events
timeFrame: Day 1
Secondary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: 90 days post procedure
measure: Change in NIH Stroke Scale (NIHSS)
timeFrame: 24 hours
measure: Number of neurovascular guidewires required per case
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Reade De Leacy, MD
role: PRINCIPAL_INVESTIGATOR
References: