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临床试验/NCT05063630
NCT05063630Unknown不适用

Intracranial Stenting in Non-acute Symptomatic Ischemic Stroke: an Open-label, Randomised Controlled Trial

Can Tho Stroke International Services Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery.

研究概览

简要总结

In non-acute symptomatic ischemic stroke, the decision-making of medical treatment plus intracranial stenting has been more and more popular, especially in patients with intracranial large severe stenosis or occlusive artery. Nonetheless, there is no evidence from randomized controlled trials evaluating the efficacy of this treatment after the Wingspan Stent System Post Market Surveillance (WEAVE) and Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN) trial compared with medical treatment alone. This trial was to investigate whether medical treatment plus intracranial stenting would prevent the recurrent ischemic stroke in the territory of the symptomatic intracranial artery during 1-year follow-up.

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 in the low risk of periprocedural stroke or death. However, this conclusion has influenced the role of intracranial stenting in the ischemic stroke treatment and recovery time for a long time because of the unproper patient selection of this trial such as no evidence of medical failure, intracranial stenting earlier than 7 days after the stroke and intracranial stenting in patients with transient ischemic attacks only. Recently, the Food and Drug Administration (FDA) mandated study about intracranial stenting, 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 WOVEN study. 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 in the world and a paucity of evidence from randomized trials, the purpose of this trial was to compare this treatment versus medical one in the intracranial large severe stenosis or occlusive artery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Evidence of intracranial large severe stenosis or occlusive artery in angiography.
  • Absence of intracranial hemorrhage.
  • Premorbid mRS score is ≤
  • Recurrent stroke in the target territory during the medical treatment for ischemic stroke prevention.

排除标准

  • Tandem lesion.
  • Loss to follow-up after discharge.
  • A severe or fatal combined illness before acute ischemic stroke.
  • Progressive neurologic deficit within 7 days after acute ischemic stroke.
  • Large middle cerebral artery infarct within 30 days after acute ischemic stroke.

研究组 & 干预措施

Medical treatment plus intracranial stenting (MT plus IS)

Experimental

This group will be both given medical treatment (aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter) and performed with intracranial stenting.

干预措施: Medical treatment plus intracranial stenting (Procedure)

Medical treatment alone (MT)

Active Comparator

This group will be given medical treatment including aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter.

干预措施: Medical treatment alone (Drug)

结局指标

主要结局

Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery.

时间窗: During 1 year after randomization.

Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery.

次要结局

  • Rate of ischemic stroke recovery of the qualifying lesion in the territory of the symptomatic intracranial artery.(During 3 months after randomization..)
  • Death rate of the qualifying lesion in the territory of the symptomatic intracranial artery.(During 1 year after randomization.)

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 (1)

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