Abbott公司将开展颈动脉支架预防脑卒中的临床试验

一项新的临床试验，属于同类中的第一个，将在无症状患者中比较颈动脉支架与颈动脉手术（也叫做颈动脉内膜切除术或者CEA）的优劣，这些患者通常都被建议接受手术。

象冠状动脉一样，颈动脉也会被斑块沉积物阻塞，这往往会导致脑卒中。实际上，大约有25％的脑卒中患者是由于颈动脉疾病引起的。颈动脉是大脑血供的主要动脉。由于缺乏临床资料，在能够接受手术的无症状患者中使用颈动脉支架系统尚未得到美国食品药品管理局的批准。大约75％的脑卒中患者是没有明显症状的。

该临床试验叫做无症状颈动脉试验，或者ACT I，由Abbott实验室(Abbott Park, IL, USA; www.abbott.com)开展的。试验的CAS臂将使用Xact颈动脉支架系统以及由Abbott血管设备部门开发的Emboshield保护系统。这些设计都是专门用于颈动脉支架方案。试验将包括美国多达50家医院涉及大约1500例患者，在对患者随访1年后获得初始终点数据。

Abbott血管设备公司总裁Robert B.Hance指出：“ACT I将对所有由于颈动脉疾病而面临脑卒中风险的患者采用微创手术，从而为患者带来巨大益处。ACT I试验在帮助患者避免脑卒中发作、延长寿命改善生命质量方面，开展了一个崭新的发展阶段。”

Groundbreaking Trial in Stroke Prevention
 
A new trial, the first of its kind, will compare carotid artery stenting (CAS) to carotid artery surgery, also known as carotid endarterectomy or CEA, in asymptomatic patients who normally would be referred for surgery.

Like coronary arteries, the carotid arteries can become clogged with plaque deposits, which can lead to stroke. In fact, about 25% of all strokes are caused by carotid artery disease. The carotid arteries are the primary suppliers of blood to the brain. Carotid artery stent systems have not yet been approved by the U.S. Food and Drug Administration (FDA) in asymptomatic patients healthy enough to undergo surgery due to lack of clinical data. About 75% of all stroke patients are asymptomatic.

Called the asymptomatic carotid trial, or ACT I, the trial is being conducted by Abbott Laboratories (Abbott Park, IL, USA; www.abbott.com). The CAS arm of the trial will use the Xact carotid stent system and Emboshield protection system developed by Abbott’s Vascular Devices division. These were designed together specifically for carotid stenting procedures. The trial will involve up to 50 hospitals in the United States and around 1,500 patients, with primary endpoint data submitted after one year of patient follow-up.

“ACT I represents a major step toward bringing the benefits of minimally-invasive procedures to all patients at risk of stroke due to carotid artery disease,” noted Robert B. Hance, president of Abbott Vascular Devices. “The ACT I trial sets the stage for a new phase in helping patients avoid strokes and live longer, healthier lives.”