Wingspan One Year Vascular Imaging Events and Neurologic Outcomes

Study Overview
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Brief Summary
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The purpose of the study is to determine the one-year post stenting outcomes in patients who were treated with the Wingspan stent on-label in the WEAVE trial. This includes both the assessment of any stroke, hemorrhage, or death, as well as assessment of delayed imaging results to determine the re-stenosis rate of the stents in these patients.

Detailed Description
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The current study is a retrospective chart and imaging review of the 152 patients enrolled in the WEAVE trial to determine the one-year outcomes for these patients. This includes both the assessment of any stroke, hemorrhage, or death, as well as assessment of delayed imaging results to determine the re-stenosis rate of the stents in these patients and the medication regimen in those patients who had symptomatic re-stenosis. The subjects for this study are pre-defined as the 152 patients who had placement of a Wingspan stent for treatment of their intracranial artery stenosis that had symptoms of stroke and 70% or greater arterial stenosis. The study will be conducted at 24 sites in the United States. It is expected that up to 152 patients' records will be assessed for follow up data analysis. Patient's information will be included in the study if they were enrolled in the WEAVE Trial and had placement of a Wingspan stent in its on-label usage indication between 12/1/2013 and 10/31/2017. Follow up information from the patients' charts will be extracted out to the one-year interval following stenting up to December 2018.

Official Title
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Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN)

Conditions
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Intracranial Atherosclerotic Disease (ICAD)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for this study are the 152 patients stented in the WEAVE trial on-label. The patients had the following inclusion criteria: Age 18-80 Intracranial artery stenosis greater or equal to 70% stenosis Target artery 2 mm or larger Presented with stroke while on medical therapy for stroke prevention Prior stroke in the target territory Modified Rankin Score of 3 or better (neurologic function) Treated greater than 7 days after their last stroke Treated with the Wingspan stent by an approved trial NeuroInterventionalist Exclusion Criteria: Patients treated outside of the trial or who did not meet the entry criteria. Patients that had stent treatment for arterial dissection Patients that had extra-cranial stenosis Patients outside the age range of the study Patients treated less than 8 days from their stroke.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year stroke rate following placement of Wingspan stent in this patient cohort | 1-year stroke rate following placement of Wingspan stent in this patient cohort | 1 year | 
| 1-year death rate following placement of Wingspan stent in this patient cohort | 1-year death rate following placement of Wingspan stent in this patient cohort | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic re-stenosis rates of the patient group. | Symptomatic re-stenosis rates of the patient group. | 1 year | 
| Severity of the strokes/index event that occurred in that patient group. | Severity of the strokes/index event that occurred in that patient group. | 1 year |