Prospective, Randomized, Single Center Study of Atherothrombotic and Thromboembolic Events After Carotid Artery Stenting Using Transfemoral and Transradial Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Cerebral embolism
研究概览
简要总结
The aim is to compare the safety of using transfemoral and transradial approach in patient undergoing carotid arteries stenting.
详细描述
The use of transradial approach in carotid arteries stenting can significantly decrease the amount of adverse events associated with transfemoral approach such as bleeding or hematoma. Otherwise providing transradial approach is fraught with technical difficulties of common carotid artery canulation that can result in embolic complications. Taking into account the absence of studies in this area of medicine, providing investigation evaluating parameters of safety for both methodics is very actual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic patients with internal carotid artery stenosis(>50%)
- •Asymptomatic patients with internal carotid artery stenosis(>60%)
- •Anatomy of internal carotid artery applicable for stent implantation and use of embolic protection device
排除标准
- •Stroke, myocardial infarction or underwent operative treatment within 1 month
- •Prior carotid artery stenting
- •Cerebral vessels aneurisms/ malformations
- •Subclavian artery/ brachiocephalic trunk stenosis
- •Contraindications for antiplatelet or/and anticoagulation therapy
结局指标
主要结局
Cerebral embolism
时间窗: during 24 hours after carotid artery stenting
Amount of intraoperative micro- and macroembolic complications evaluated as an occurence of new ipsilateral ischemic lesions estimated due to brain MRI data.
次要结局
- Neurocognitive disorders(before and 30 days after carotid artery stenting)
- Device success(intraoperative)
- Lesion success(intraoperative)
- Cerebral embolism(intraoperative)
- MACCE(during 30 days after carotid artery stenting)
- Operative access complications(intraoperative/ 1 day after operation)
- Fluoroscopic time(intraoperative)
- In-hospital procedure success(Within 5-day hospitalization)