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OpenTrials
Completed

NCT Number: NCT03438565

SURE 18 Registry -Asahi Chikai Black 18 in LVO Stroke

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.

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Key information

Conditions

Occlusive Stroke

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Asahi Chikai Black 18 neurovascular guidewire

Device

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.

Primary outcomes

  1. Time to clot engagement

    Time frame: 30 days

    Time from guide catheter placement within the target ICA to clot engagement

  2. Number of device related serious adverse events

    Time frame: Day 1

    Safety profile as measured by number of Intra-procedural device related serious adverse events

Secondary outcomes

  1. Modified Rankin Scale (mRS)

    Time frame: 90 days post procedure

    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

  2. Change in NIH Stroke Scale (NIHSS)

    Time frame: 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.

  3. Number of neurovascular guidewires required per case

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Asahi Intecc USA Inc

Registry information

Official study title

Safety and Utility Profile of the Asahi Chikai Black 18 neuRovascular guidewirE in Large Vessel Occlusive Stroke: SURE 18 Registry

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2018
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.