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The purpose of this study is to compare the effectiveness of treating blockages in carotid arteries with either carotid endarterectomy (CEA, surgery) OR carotid stenting (CAS), using the carotid stent system with or without the embolic protection system, in preventing stroke, heart attack and death.
Description: CREST is a NIH-funded, multi-center, randomized clinical trial comparing a minimally invasive procedure called carotid artery stenting (CAS) with the surgical procedure called carotid endarterectomy (CEA) to treat patients who have a build of arteriosclerosis or plaque in the carotid arteries (carotid artery disease). Patients with carotid artery disease may be at risk for stroke if particles of atherosclerotic plaque are dislodged from the arteries. In this trial, half the patients will be assigned to carotid stenting and half to carotid endarterectomy. Carotid endarterectomy is an operation in which doctors clean out and repair the carotid artery supplying blood to the brain, the carotid artery. Carotid artery stenting is a procedure where a metal device called a stent is placed in a narrowed part of the carotid artery to cover the plaque and hold the vessel open. During the procedure, a small umbrella-like instrument called an embolic protection device is placed above the stent to catch any particles that might break away. Participants in the trial will also receive the best known medical management to reduce their risk factors for stroke including control of high blood pressure, obesity and diabetes, elimination of smoking, and emphasis on a low-fat, low cholesterol diet. Whether the patient has carotid surgery or carotid stenting, they will need to return to visit their doctor for follow-up examinations at one month, six months, twelve months after the treatment, and every six months thereafter until the study is completed, which may be for up to four years. They will also be contacted via telephone by the research staff 3 months after treatment every 6 months thereafter up to 4 years.
Abbott Vascular is the manufacturer of the devices in this Trial. The carotid stent and embolic protection procedures are under investigation in this study. Although the carotid stent system and the embolic protection system are not yet approved for general use by the Food and Drug Administration (FDA), the FDA has approved these devices for use in this study.
Active, not recruiting
Patients are eligible if they have carotid stenosis ³50% (by angiography) or ³70% (by ultrasound) and have had cerebrovascular symptoms (TIA, amaurosis fugax, minor or non-disabling stroke) within 180 days; these are considered symptomatic patients. Individuals who have carotid stenosis ³60% (by angiography) or ³70% (by ultrasound) and have not had any cerebrovascular symptoms in the past 180 days are eligible as asymptomatic patients.
Phase: Phase 3
Trial ID: 500NINDS
Not Accepting Healthy Volunteers