SURE 18 Registry -Asahi Chikai Black 18 in LVO Stroke

Mount Sinai Health System

Status: Completed

Conditions: Occlusive Stroke

Treatments: Device: Asahi Chikai Black 18 neurovascular guidewire

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03438565

GCO 17-2723

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Participants with intracranial large vessel occlusive stroke

Description:

50 patients who have been treated with the Asahi Chikai Black 18 neurovascular guidewire.

Treatment:

Device: Asahi Chikai Black 18 neurovascular guidewire

Historical Control Group

Description:

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.