Study at Franciscan Health Indianapolis Seeks Optimal Stroke Prevention Options
INDIANAPOLIS, Indiana – The first patients are being enrolled at Franciscan Health Indianapolis in a major study for the treatment of carotid artery disease. Three established treatments for this condition are intensive medical management, carotid endarterectomy (CEA) or carotid artery stenting (CAS).
All three treatment methods produce excellent outcomes in the setting of narrowing of the carotid arteries.
The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis study (CREST-2) is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health. Franciscan Health is one of 120 medical centers in the United States and Canada – and the only hospital in Central Indiana – participating in the study.
"To qualify, participants must be at least 35 years old, have a significant narrowing of one carotid artery with at least 70 percent blockage, and have no history of stroke or transient ischemic attack – often called a 'mini stroke' – within the last six months," said William Berg, MD, FACC, FSCAI, medical director and interventional cardiologist at Franciscan Health Heart Center Indianapolis.
"Physicians want to identify the best way to prevent strokes in people who have a narrowing in their carotid artery,” said Charles Kiell, MD, FACS, co-medical director and vascular surgeon of the Franciscan Health Vascular Program. The CREST-2 trial is designed to compare three different treatment methods of stroke prevention to find the safest and most effective treatment.
"The stroke prevention methods include intensive medical management or intensive medical management combined with carotid endarterectomy, a procedure in which surgeons clean out and repair a main artery supplying blood to the brain," said Dr. Kiell. "The other stroke prevention methods include intensive medical management or intensive medical management combined with carotid stenting in which a metal device called a stent is place in the narrowed portion of the carotid artery to cover the plaque buildup and hold the vessel open."
"During the procedure, a small umbrella-shaped instrument is placed above the stent to capture any particles that might break away," added Dr. Berg.
The study is randomized, meaning participants are allocated by chance to receive intensive medical management alone or intensive medical management in combination with one of the two revascularization procedures (CEA or CAS).
Stroke is the fifth most common cause of death in the United States and is the leading cause of disability in adults. Risk factors include high blood pressure, high cholesterol, diabetes, tobacco use, excess body weight and physical inactivity. Such factors can be modified by intensive medical management and lifestyle changes.
In CREST-2, intensive medical management includes using aspirin to prevent blood clot formation, medications to lower blood pressure and bad (LDL) cholesterol, and a health coach to review ways to help patients quit tobacco, manage their weight and increase physical activity.
The carotid surgery and stenting procedures in CREST-2 are performed only by physicians who have demonstrated safety and expertise. Of the study participants about half will be assigned to the carotid endarterectomy approach and the other half will receive the stent.
For more information about the trial and other clinical studies at Franciscan Health Indianapolis, contact Stephanie Alford at (317) 893-1712, or go to https://www.franciscanhealth.org/health-care-services/clinical-trials-105.
By Joe Stuteville
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