Immediate and Long-term Results of Carotid Endarterectomy and Stenting in the Acute Stage of Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of Myocardial infarction (%)
研究概览
简要总结
The objective of this clinical trial is to compare immediate and long-term results of carotid endarterectomy and carotid stenting in acute period of ischemic stroke. Patients who presented with acute stage of ischemic stroke will be treated by carotid artery stenting in 50 cases and by carotid endarterectomy in 50 cases under regional anesthesia.
Patient inclusion criteria:
- Ischemic stroke in the middle cerebral artery territory
- Ipsilateral stenosis of the internal carotid artery more than 50%
- Neurological deficit at the time of surgical treatment: the modified Rankin scale (mRs) score of 0-4 and the US National Institutes of Health (NIHSS) stroke scale score no more than 12
- The size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply
- Terms of operation: from 1 to 28 days from the moment of ischemic stroke
The primary intra-hospital and/or 30-day study endpoints:
- Perioperative ipsilateral ischemic stroke.
- Any stroke: contralateral ischemic or any hemorrhagic stroke.
- Myocardial infarction.
- Hemorrhagic complications that required surgical revision of the operating wound or transfusion of blood components.
- Surgical site infection
- Death
- Main adverse cardiovascular events (stroke + myocardial infarction + death).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •1. Ischemic stroke in the middle cerebral artery territory
- •Ipsilateral stenosis of the internal carotid artery more than 50%
- •Neurological deficit at the time of surgical treatment: the modified Rankin scale (mRs) score of 0-4 and the US National Institutes of Health (NIHSS) stroke scale score no more than 12
- •The size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply
- •Terms of operation: from 1 to 28 days from the moment of ischemic strok
排除标准
- 未提供
研究组 & 干预措施
Patients in acute period of Ischaemic Stroke
干预措施: Carotid Artery Stent Placement (Procedure)
Patients in acute period of Ischaemic Stroke
干预措施: carotid endarterectomy (Procedure)
结局指标
主要结局
Rate of Myocardial infarction (%)
时间窗: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Rate of main adverse cardiovascular events (%)
时间窗: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Rate of Hemorrhagic complications (%)
时间窗: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
The primary outcome measure was 30-day postoperative intracerebral hemorrhage (ICH)
Rate of perioperative ipsilateral ischemic stroke (%)
时间窗: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
The primary endpoint was ipsilateral stroke \< 30 days.
Rate of any stroke (%)
时间窗: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Rate of Surgical site infection (%)
时间窗: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Rate of Death (%)
时间窗: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
次要结局
未报告次要终点
研究者
Pryamikov Aleksandr
MD, PhD (DMedSc [Russia]), Associate Professor
Pirogov Russian National Research Medical University