SURE 18 Registry -Asahi Chikai Black 18 in LVO Stroke

Occlusive Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438565
• Other study ID #: GCO 17-2723
• Status: Completed
• Start date: March 18, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: March 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Occlusive Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Asahi Intecc USA Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clot engagement	Time from guide catheter placement within the target ICA to clot engagement	30 days
Primary	Number of device related serious adverse events	Safety profile as measured by number of Intra-procedural device related serious adverse events	Day 1
Secondary	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
Secondary	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
Secondary	Number of neurovascular guidewires required per case		Day 1