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临床试验/NCT03999983
NCT03999983招募中不适用

Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)

St. Louis University10 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
10
主要终点
Incidence of recurrent stroke or death

研究概览

简要总结

A retrospective and prospective registry of patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS).

详细描述

A retrospective registry of stenting plus medical management for the prevention of recurrent stroke in patients with symptomatic Vertebral Artery origin Stenosis (VAOS). This study is collecting information on clinical outcomes up to 18 months post-treatment.

On January 6, 2025, VOTER was changed from prospective to retrospective.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18 and 90 years of age
  • Patient has experienced a posterior circulation ischemic event
  • Patient has angiographically confirmed bilateral vertebral artery origin disease (Hypoplasia, occlusion, or stenosis).
  • Patient has >50% stenosis on the side being targeted for therapy

排除标准

  • Pregnant women
  • Contrast Indication to the use of anti-platelet drugs
  • There is tandem vertebral or basilar artery stenosis
  • The serum creatinin is >2.5
  • Baseline modified Rankin score is >3
  • < 5 years life expectancy

结局指标

主要结局

Incidence of recurrent stroke or death

时间窗: 1 Year post-treatment

Recurrent stroke of any type or death from any cause

次要结局

  • Incidence of Restenosis(1 Year post-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Randall C. Edgell, MD, FSVIN

Professor, Department of Neurology

St. Louis University

研究点 (10)

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