December 09, 2002
Genesis Participates In Clinical Trial For Peripheral Vascular Disease
New Clinical Trial Holds Hope for Patients Previously Untreatable
Davenport, IA - Heart Institute researchers at Genesis Medical Center recently began helping patients suffering from peripheral vascular disease who had previously been untreatable. Genesis was selected as one of 15 sites nationwide to participate in a clinical trial that uses fiber optic and radio frequency technology to facilitate a small opening in arteries completely blocked by calcified plaque and fatty deposits which builds up along artery walls and can block blood circulation.
Each year many Americans, particularly those aged 50+, suffer from blocked arteries in their extremities, such as feet and legs. Medical experts estimate that some 8-12 million American suffer from peripheral artery disease, and the ensuing heart attacks or strokes it causes, leads to significant health problems, even death.1 For patients who cannot be treated surgically and whose traditional interventional angioplasty procedures have failed, a new device being tested provides a new approach to interventional angioplasty treatment.
The clinical trial is testing a guide wire developed by IntraLuminal Therapeutics, a medical device manufacturer based in San Diego, CA. "This is the first use of radio frequency technology for this treatment application," says interventional cardiologist Eric Dippel, M.D., Cardiovascular Medicine, P.C., and principal investigator for the Genesis portion of the clinical trial. "Basically this device allows me to look through the guide wire and 'see' into the plaque so I can navigate through the blockage. Once a small pathway has been opened, then I can use the traditional angioplasty treatment which includes use of balloons to open the artery and stents to keep the artery open."
Dennis McConnell, 65, Clinton, is one of the first Quad-City area heart patients to undergo the procedure with the new guide wire. "I had previously attempted to open his arteries with traditional interventional methods and found I could not move through the blockage," says Dr. Dippel. "I'm thrilled that this clinical trial gives us new technology to help him and other patients like him." Mr. McConnell says he looks forward to taking long walks during his vacations in Door County, Wisconsin: something he has been unable to do.
The IntraLuminal Therapeutics guide wire system uses optical coherence Reflectometry (OCR), along with a controlled radio frequency (RF) energy source, to aid in navigating through and crossing total occlusions in the vasculature. The Safe-CrossTM system includes a guide wire with an optic fiber inside its lumen, an OCR unit to provide the operator with forward-looking guidance to navigate through the total occlusion, and RF energy which may be delivered from the guide wire to aid crossing highly calcified total lesions in the heart. Once the guide wire is across the total occlusion, the lesion can be definitively treated with conventional angioplasty balloons or stent devices.
The trial, known as GRIP, is a prospective, controlled registry involving approximately 75 patients nationwide. The aim of the study is to determine the safety and effectiveness of the Safe-Cross™ Guided Radio Frequency Total Occlusion Crossing System to traverse total occlusions in native peripheral arteries that conventional guide wires have failed to cross. Study endpoints include evaluation of clinical success, defined as crossing the occlusion without angiographic complications, and complication rate.
"The cardiac program at Genesis is committed to providing our patients a wide variety of options through expanding research," says Dr. Dippel. Genesis Heart Institute interventional cardiologists perform more than 2,500 angioplasty procedures each year including 400 procedures on peripheral arteries. For more information on participating in this clinical trial, call research coordinator Vickie Takes at 563-421-3941.
Genesis Heart Institute is a regional network of heart specialists treating patients from more than 12 counties in Iowa and Illinois. The Institute serves as a link between heart specialists and other physicians throughout the region, providing patients new advances in detection, treatment and management of heart disease. For more information about this clinical trial or other national studies underway, visit the Genesis Heart Institute website at www.genesisheart.com.
1 "Peripheral Arterial Disease Detection, Awareness, and Treatment in Primary Care", authors Alan T. Hirsch, MD; Michale H Criqui, MD, et al. JAMA. Vole 286, No. 11, September 19, 2001.
