Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- 1-year death rate following placement of Wingspan stent in this patient cohort
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
1-year death rate following placement of Wingspan stent in this patient cohort
时间窗: 1 year
1-year death rate following placement of Wingspan stent in this patient cohort
1-year stroke rate following placement of Wingspan stent in this patient cohort
时间窗: 1 year
1-year stroke rate following placement of Wingspan stent in this patient cohort
次要结局
- Symptomatic re-stenosis rates of the patient group.(1 year)
- Severity of the strokes/index event that occurred in that patient group.(1 year)
研究者
Michael J. Alexander, MD
Professor and Vice Chairman, Department of Neurosurgery, Director of the Cedars-Sinai Neurovascular Center, Co-Director, Comprehensive Stroke Center
Cedars-Sinai Medical Center