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SURE 18 Registry -Asahi Chikai Black 18 in LVO Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438565
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
Asahi Intecc USA Inc
Information provided by (Responsible Party):
Reade A De Leacy, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment
Occlusive Stroke 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 90 Days
Official Title: Safety and Utility Profile of the Asahi Chikai Black 18 neuRovascular guidewirE in Large Vessel Occlusive Stroke: SURE 18 Registry
Actual Study Start Date : March 18, 2018
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  1. Modified Rankin Scale (mRS) [ Time Frame: 90 days post procedure ]

    0 No symptoms at all

    1. No significant disability despite symptoms; able to carry out all usual duties and activities
    2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    3. Moderate disability; requiring some help, but able to walk without assistance
    4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438565


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Asahi Intecc USA Inc
Investigators
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Principal Investigator: Reade De Leacy, MD Icahn School of Medicine at Mount Sinai
Additional Information:

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Responsible Party: Reade A De Leacy, Assistant Professor of Neurosurgery and Radiology; Director of Neurointerventional Spine, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03438565    
Other Study ID Numbers: GCO 17-2723
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Reade A De Leacy, Icahn School of Medicine at Mount Sinai:
Asahi Chikai Black 18 Neurovascular Guidewire
Prospective
Retrospective
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases