Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
NCT Number: NCT04221984
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.
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All sexes
Observational
Los Angeles, California, 90048, United States
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The patients had the following inclusion criteria:
Exclusion criteria
Time frame: 1 year
1-year stroke rate following placement of Wingspan stent in this patient cohort
Time frame: 1 year
1-year death rate following placement of Wingspan stent in this patient cohort
Time frame: 1 year
Symptomatic re-stenosis rates of the patient group.
Time frame: 1 year
Severity of the strokes/index event that occurred in that patient group.
Cedars-Sinai Medical Center
Other
Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN)
Acronym: WOVEN
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