Abbott公司將開展頸動脈支架預防腦卒中的臨床試驗

一項新的臨床試驗，屬于同類中的第一個，將在無癥狀患者中比較頸動脈支架與頸動脈手術（也叫做頸動脈內膜切除術或者CEA）的優劣，這些患者通常都被建議接受手術。

象冠狀動脈一樣，頸動脈也會被斑塊沉積物阻塞，這往往會導致腦卒中。實際上，大約有25％的腦卒中患者是由于頸動脈疾病引起的。頸動脈是大腦血供的主要動脈。由于缺乏臨床資料，在能夠接受手術的無癥狀患者中使用頸動脈支架系統尚未得到美國食品藥品管理局的批準。大約75％的腦卒中患者是沒有明顯癥狀的。

該臨床試驗叫做無癥狀頸動脈試驗，或者ACT I，由Abbott實驗室(Abbott Park, IL, USA; www.abbott.com)開展的。試驗的CAS臂將使用Xact頸動脈支架系統以及由Abbott血管設備部門開發的Emboshield保護系統。這些設計都是專門用于頸動脈支架方案。試驗將包括美國多達50家醫院涉及大約1500例患者，在對患者隨訪1年后獲得初始終點數據。

Abbott血管設備公司總裁Robert B.Hance指出：“ACT I將對所有由于頸動脈疾病而面臨腦卒中風險的患者采用微創手術，從而為患者帶來巨大益處。ACT I試驗在幫助患者避免腦卒中發作、延長壽命改善生命質量方面，開展了一個嶄新的發展階段。”

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.”