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

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.

Study Overview

• Status: Completed
• Conditions: Occlusive Stroke
• Intervention / Treatment: Device: Asahi Chikai Black 18 neurovascular guidewire

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School Of Medicine At Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with intracranial large vessel occlusive stroke; 50 patients who have been treated with the Asahi Chikai Black 18 neurovascular guidewire.	Device: Asahi Chikai Black 18 neurovascular guidewire; 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.
Historical Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale (mRS)	0 No symptoms at all; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; Moderate disability; requiring some help, but able to walk without assistance; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead	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.	24 hours
Number of neurovascular guidewires required per case		Day 1

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Asahi Intecc USA Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 18, 2018
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ACTUAL): February 1, 2020

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (ACTUAL): February 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 7, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Prospective; Retrospective; Asahi Chikai Black 18 Neurovascular Guidewire
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: GCO 17-2723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes