Dec 21, 2000
Guidant and the University of Medicine and Dentistry of New Jersey Launch Clinical Trial to Study Carotid Artery Stenting and Carotid Endarterectom

Landmark Study Examines Minimally Invasive Alternative for Treating Carotid Artery Disease

Indianapolis, Ind., Santa Clara, Calif. and Newark, N.J. - Guidant Corporation (NYSE and PCX: GDT) and the University of Medicine and Dentistry of New Jersey have launched a landmark clinical trial to evaluate the efficacy of carotid artery stenting as a means of preventing stroke by comparing it to the standard method of treatment-carotid endarterectomy. Called CREST (Carotid Revascularization Endarterectomy-Stenting Trial), the multicenter clinical trial is being funded by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH) and will enroll 2,500 patients at 60 centers throughout the United States.

The first patient was successfully treated on Dec. 7 by Nick Hopkins, M.D., at the State University of New York at Buffalo. Dr. Hopkins implanted the patient with Guidant's investigational ACCULINK(tm) Carotid Stent System, which is designed to open carotid arteries that have been occluded due to atherosclerosis. Carotid arteries, located on either side of the neck, carry blood up the neck to the brain. Robert W. Hobson II, M.D., of the New Jersey Medical School is the principal investigator of CREST and is responsible to oversee its activities nationally.

"The CREST protocol is an important development in the treatment of carotid artery disease," said Hobson. "Currently patients suffering from this life-threatening disease have only two treatment options: surgical intervention via carotid endarterectomy and drug therapy. In this clinical trial, we will investigate another option - carotid stenting - which may be an effective alternative to carotid endarterectomy."

Guidant's investigational ACCULINK Stent has been selected as the exclusive stent for the CREST trial. The ACCULINK System, designed specifically for use in the carotid anatomy, features a self-expanding stent that is available in both tapered and straight configurations to fit a patient's unique anatomy. The ACCULINK System is designed for precise deployment over the atherosclerotic plaque in the carotid artery.

Many physicians believe carotid stenting is a promising, less-invasive therapy for reducing the risk of strokes caused by carotid artery disease. Although carotid endarterectomy is a safe procedure, some of the perceived benefits of carotid stenting include: avoiding a surgical incision, reduced procedure time and the potential of reduced procedural complications in select groups of patients. The minimally invasive carotid artery stenting procedure is accomplished by using a catheter that is inserted into a small puncture in the femoral artery, located in the groin. A delivery catheter is advanced through the patient's vasculature to the carotid artery, where the stent is deployed at the site of the atherosclerotic lesion.

The traditional carotid endarterectomy treatment, however, requires the physician to make a surgical incision in the patient's neck at the site of the blockage, which allows the surgeon to then remove the plaque inside the artery. Approximately 144,000 of these surgical procedures are performed each year.

"Guidant is pleased to be a part of this clinically significant trial," said John M. Capek, Ph.D., president of Guidant's Vascular Intervention Group. "We're hopeful that the CREST clinical trial will be successful in establishing stenting with Guidant's ACCULINK device as a viable alternative to the traditional surgical method of preventing strokes that may be caused by carotid artery disease."

Data from the American Heart Association (AHA) classifies stroke as the third most common cause of death and the number one cause of disability in adults. Approximately 600,000 strokes are reported annually in the United States, with about 150,000 strokes each year resulting in death. The AHA estimates that 20-30 percent of all strokes are caused when particles of atherosclerotic plaque are dislodged from the carotid artery wall. As these particles travel through the blood stream they can occlude vessels in the brain, preventing adequate blood flow and causing the condition known as stroke.

A global leader in the medical technology industry, Guidant Corporation provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease.

NINDS, an agency of the U.S. Federal Government and a component of the National Institutes of Health and the U.S. Public Health Service, is a lead agency for the Congressionally-designated "Decade of the Brain," and the leading supporter of biomedical research on disorders of the brain and nervous system.