SURE 18 Registry -Asahi Chikai Black 18 in LVO Stroke
|ClinicalTrials.gov Identifier: NCT03438565|
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment|
|Occlusive Stroke||Device: Asahi Chikai Black 18 neurovascular guidewire|
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 [Patient Registry]|
|Actual Enrollment :||100 participants|
|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|
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.
- Time to clot engagement [ Time Frame: 30 days ]Time from guide catheter placement within the target ICA to clot engagement
- 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
- 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
- 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.
- Number of neurovascular guidewires required per case [ Time Frame: Day 1 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438565
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Reade De Leacy, MD||Icahn School of Medicine at Mount Sinai|