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.”




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