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临床试验/NCT05947994
NCT05947994已完成不适用

Elucidate Outcomes of Elective High-grade/Total Occlusion Intracranial Arteries Using Low-profile Self-expanding Stent

Can Tho Stroke International Services Hospital2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
156
试验地点
2
主要终点
Rate of the critical adverse events

研究概览

简要总结

Intracranial atherosclerotic disease (ICAD) is a high prevalent cause of stroke, especially in Asian population and can be categorized as either symptomatic (resulting in acute ischemic stroke) or asymptomatic. Treatment for patients who failed with optimal medical therapy (OMT) is still elucidating.

详细描述

In symptomatic ischemic stroke due to intracranial large severe stenosis or occlusive artery, the choice for treatment has remained controversial after results of the Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial because it demonstrated that the efficacy of medical treatment was superior to intracranial stenting (IS) in the low risk of periprocedural stroke or death. However, this conclusion has influenced the role of IS in the secondary prevention of ischemic stroke and recovery time for a long time because of the improper patient selection of this trial such as no evidence of medical failure, IS in case of moderate intracranial stenosis and IS in patients with transient ischemic attacks only. Recently, the Food and Drug Administration (FDA) mandated study about IS, the Wingspan Stent System Post Market Surveillance (WEAVE) trial, reported not only 97.4% patients with no complication at 72 hours, but also a relatively low 8.5% recurrent stroke and death rate during 1 year in the Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN) study about Wingspan stent (Stryker, Kalamazoo, MI). In case of the symptomatic stenosis greater than 70%, the probability of recurrent stroke and transient ischemic attack in the territory of the symptomatic stenotic artery in 1 year was 23% and 14%, respectively, despite treatment with antithrombotic therapy and standard management of vascular risk. Given a lot of patients with symptomatic ischemic stroke who have some adjustable indications for intracranial stenting deployment with Wingspan stent in the world and a paucity of evidence from the comprehensive stroke centers about other self-expanding stents, Credo stent (Acandis GmbH, Pforzheim, Germany), our purpose was to compare the periprocedural complication and rate of 1-year recurrent ischemic stroke associating to the IS between beyond 7 days from acute stage and the progressive ischemic stroke time.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • Evidence of severe intracranial stenosis
  • Target intracranial artery ≥ 2 mm
  • Absence of intracranial hemorrhage
  • Procedure treated with the Credo stent (Acandis, Pforzheim, Germany)

排除标准

  • Premorbid modified Rankin Scale (mRS) score ≥ 2
  • Intracranial rescue stenting for acute ischemic stroke within 24 hours
  • Loss to follow-up after discharge
  • Systemic lupus erythematosus
  • More procedures at the same time

结局指标

主要结局

Rate of the critical adverse events

时间窗: After procedure within 24 hours

The critical adverse events: intracranial hemorrhage, new infarct

Rate of 1-year recurrent ischemic stroke

时间窗: During 1 year after procedure

Rate of 1-year recurrent ischemic stroke in the territory of the symptomatic intracranial artery

次要结局

未报告次要终点

研究者

发起方
Can Tho Stroke International Services Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Cuong Tran Chi

Director - Doctor

Can Tho Stroke International Services Hospital

研究点 (2)

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