Impact of Aspiration Thrombectomy During Carotid Stenting on New Ischemic Lesions Identified by Diffusion-Weighted Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of new, ischemic foci
研究概览
简要总结
The purpose of this study is to determine whether aspiration thrombectomy following carotid stent deployment will reduce the number of procedure related signals as identified by diffusion weighted MRI of the brain.
详细描述
Studies have demonstrated that carotid artery stenting is a safe and effective alternative to carotid endarterectomy for high or standard risk patients with symptomatic stenosis. Despite the routine use of embolic protection devices, numerous studies have shown that carotid stenting is associated with a higher degree of intracranial emboli by diffusion-weighted MRI of the brain. A potential solution to minimize this effect is the use of aspiration prior to distal embolic protection removal.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICA stenosis greater than 50 percent by carotid angiography
- •Documented hemispheric ischemic stroke, TIA, amaurosis fugax, or retinal stroke in the last six months ipsilateral to the stented lesion
排除标准
- •Subject less than 40 years of age
- •Pregnant subjects
- •Asymptomatic carotid stenosis
- •Total occlusion of target carotid artery
- •Inability to deploy distal protection device or stent in target vessel
- •Allergy to both aspirin and approved thienopyridine anti-platelet drugs (clopidogrel/ticlopidine)
- •Multiple carotid stenoses in same vessel that cannot be covered by single stent
- •Ipsilateral intracranial stenosis requiring treatment
- •Isolated common carotid stenosis
- •Stenosis less than 50 percent by angiography
- •Chronic or paroxysmal atrial fibrillation not treated with warfarin or dabigatran.
- •Life expectancy less than 30 days
- •Active bleeding diathesis
- •Suspected Myocardial Infarction within 72 hours prior to carotid stenting
- •Presence of intracranial tumor arteriovenous malformations or aneurysm requiring treatment
- •Inability to undergo DWMRI
- •Unwillingness to participate or provide consent
- •Subjects using a legally authorized representative for consent for participation
- •Concurrently enrolled in another study
- •Stroke, TIA, amaurosis fugax ipsilateral to the treated lesion more than 6 months from randomization
- •Occlusive or critical ilio-femoral disease that precludes safe femoral access to the aortic arch
- •Severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries
- •Prior large stroke, multiple lacunar infarcts, or dementia
- •Stenosis that contain visible thrombus
研究组 & 干预措施
Distal Embolic Protection Only
Carotid stenting with distal embolic protection only
干预措施: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA) (Device)
Distal embolic protection and aspiration thrombectomy
Aspiration thrombectomy following stent deployment and prior to removal of distal embolic protection
干预措施: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA) (Device)
结局指标
主要结局
Number of new, ischemic foci
时间窗: 18-48 hours post procedure
Foci of restricted diffusion will be classified by their number, location, and size
次要结局
- Ischemic zone area(18-48 hours post stenting)
研究者
James Joye
Chief Medical Officer
Fogarty Clinical Research Inc.