一項(xiàng)新的臨床試驗(yàn)，屬于同類(lèi)中的第一個(gè)，將在無(wú)癥狀患者中比較頸動(dòng)脈支架與頸動(dòng)脈手術(shù)（也叫做頸動(dòng)脈內(nèi)膜切除術(shù)或者CEA）的優(yōu)劣，這些患者通常都被建議接受手術(shù)。

象冠狀動(dòng)脈一樣，頸動(dòng)脈也會(huì)被斑塊沉積物阻塞，這往往會(huì)導(dǎo)致腦卒中。實(shí)際上，大約有25％的腦卒中患者是由于頸動(dòng)脈疾病引起的。頸動(dòng)脈是大腦血供的主要?jiǎng)用}。由于缺乏臨床資料，在能夠接受手術(shù)的無(wú)癥狀患者中使用頸動(dòng)脈支架系統(tǒng)尚未得到美國(guó)食品藥品管理局的批準(zhǔn)。大約75％的腦卒中患者是沒(méi)有明顯癥狀的。

該臨床試驗(yàn)叫做無(wú)癥狀頸動(dòng)脈試驗(yàn)，或者ACT I，由Abbott實(shí)驗(yàn)室(Abbott Park, IL, USA; www.abbott.com)開(kāi)展的。試驗(yàn)的CAS臂將使用Xact頸動(dòng)脈支架系統(tǒng)以及由Abbott血管設(shè)備部門(mén)開(kāi)發(fā)的Emboshield保護(hù)系統(tǒng)。這些設(shè)計(jì)都是專(zhuān)門(mén)用于頸動(dòng)脈支架方案。試驗(yàn)將包括美國(guó)多達(dá)50家醫(yī)院涉及大約1500例患者，在對(duì)患者隨訪1年后獲得初始終點(diǎn)數(shù)據(jù)。

Abbott血管設(shè)備公司總裁Robert B.Hance指出：“ACT I將對(duì)所有由于頸動(dòng)脈疾病而面臨腦卒中風(fēng)險(xiǎn)的患者采用微創(chuàng)手術(shù)，從而為患者帶來(lái)巨大益處。ACT I試驗(yàn)在幫助患者避免腦卒中發(fā)作、延長(zhǎng)壽命改善生命質(zhì)量方面，開(kāi)展了一個(gè)嶄新的發(fā)展階段。”

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.”