SURE 18 Registry -Asahi Chikai Black 18 in LVO Stroke

NCT03438565 | Completed FDA Device

• 1 other identifier: GCO 17-2723
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Occlusive Stroke

Keywords

Asahi Chikai Black 18 Neurovascular Guidewire; Prospective; Retrospective

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Modified Rankin Scale (mRS)

  90 days post procedure

• Change in NIH Stroke Scale (NIHSS)

  24 hours

• Number of neurovascular guidewires required per case

  Day 1

Study Arms (2)

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

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.

Interventions

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.

Participants with intracranial large vessel occlusive stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Asahi Intecc USA Inc: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Study Officials

• Reade De Leacy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurosurgery and Radiology; Director of Neurointerventional Spine

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 19, 2018
• Study Start: March 18, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)