NEWPORT BEACH, Calif., March 31 /PRNewswire/ -- The first patient in the U.S. to be enrolled in the clinical trial named “Carotid Angioplasty and Stenting vs. Endarterectomy in Asymptomatic Subjects with Significant Extracranial Carotid Occlusive Disease Trial” (ACT I) was treated yesterday at the Hoag Heart and Vascular Institute at Hoag Memorial Hospital Presbyterian in Newport Beach, CA. ACT I is the first trial to study the potential benefits of minimally invasive carotid stenting in patients who would normally undergo surgery, carotid endarterectomy (CEA), to prevent stroke.
Stroke represents the third leading cause of death and the number one cause of disability in the United States, with more than 700,000 American suffering strokes each year. Nearly 90 percent of all strokes stem from insufficient blood supply to the brain, a condition caused by narrowing or blockage of Embolic blood vessels.(1)
ACT I, sponsored by Abbott, is a multicenter, randomized study to compare carotid artery stenting to carotid artery surgery in the asymptomatic patient (those who have not displayed symptoms of stroke, but who are at risk) who normally would be referred for surgery.
“This important clinical trial challenges the final frontier in carotid therapy by comparing carotid stenting with standard CEA in asymptomatic patients. This has enormous importance since approximately 75% of carotid surgery in the country is done on such patients,” states Subbarao Myla, MD, Medical Director of Cardiovascular Research at Hoag Heart and Vascular Institute and its principal investigator for the ACT I study.
The FDA recently approved carotid artery stenting for patients who require immediate intervention to prevent stroke, but it is limited to those who have medical conditions that deem them too high-risk for surgery (i.e. previous stroke or transient ischemic attack, congestive heart failure, unstable angina, severe lung disease).
The ACT I study will enroll approximately 1500 patients in up to 50 hospitals across the U.S. Of patients who met the criteria, computer-assisted randomization will select 3-of-4 patients for carotid stenting and 1-of-4 for carotid endarterectomy. Participation in the study is voluntary.
“Participating in the ACT I study is an exciting opportunity for Hoag Heart and Vascular Institute and for our patients,” says Susan Goldberg, RN, MSN, Vice President of Cardiovascular Services for Hoag Hospital. “We are honored that Hoag was selected to contribute to this prestigious scientific study.”
Physicians performing carotid stenting in the ACT I study will utilize a specific device -- the investigational Xact(R) Carotid Stent System and Emboshield(R) Embolic Protection System manufactured by Abbott.
In the United States, the Emboshield Embolic Protection System and the Xact Carotid Stent System are investigational devices not approved for sale. Both the Emboshield and the Xact have CE Mark approval for distribution in European Union and European Free Trade Association markets.
About Hoag Memorial Hospital Presbyterian
Hoag Memorial Hospital Presbyterian (http://www.hoaghospital.org/) is a 409-bed, not-for-profit, acute care hospital located in Newport Beach, Calif. Fully accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Hoag offers a comprehensive mix of healthcare services, including Centers of Excellence in cancer, heart and vascular, orthopedics and women’s health services.
About Hoag Heart and Vascular Institute
Hoag Heart and Vascular Institute, a designated Center of Excellence at Hoag Memorial Hospital Presbyterian, is one of the preeminent cardiovascular centers on the West Coast. Specialties of Hoag Heart and Vascular Institute include diagnostic cardiology, cardiothoracic surgery, vascular surgery, endovascular diagnosis and treatment, interventional cardiology, interventional radiology, electrophysiology, cardiac rehabilitation, disease management, prevention services, and research.
(1) American Heart Association, Heart Disease and Stroke Statistics -- 2004 Update, Dallas, TX: American Heart Association
Hoag Memorial Hospital Presbyterian
CONTACT: Nancy Bartelt, Manager, Marketing Communications, Hoag MemorialHospital Presbyterian, +1-949-764-5922, NBartelt@hoaghospital.org
Web site: http://www.hoaghospital.org/