Abbott Initiates First Clinical Study of Everolimus Eluting Stent System for Patients with Peripheral Arterial Disease
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- Published on Thursday, 24 May 2007 04:00
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ABBOT PARK, IL, USA | May 23, 2007 | Abbott today announced enrollment of the first patient in the STRIDES (The SFA TReatment wIth Drug-Eluting Stents) trial, a first-in-human clinical trial in Europe designed to evaluate the use of an everolimus eluting, self-expanding stent system for patients with peripheral arterial disease in the superficial femoral artery. Marc Bosiers, M.D., at AZ Sint-Blasius Hospital in Dendermonde, Belgium, performed the first procedure.
Peripheral Artery Disease, or PAD, is characterized by fatty plaque build-up in the arteries of the legs, which leads to poor blood flow and circulation. Patients with PAD may experience muscle pain during walking, have wounds and ulcers that are slow to heal or, in the most severe cases, require amputation of the legs. Possible treatments for PAD include lifestyle modification (including cessation of smoking), medicines, balloon dilatation, metal stent placement or bypass surgery. Drug-eluting stents are not yet available for arteries in the thigh, as the stents developed for the coronary arteries are too small to be effectively implanted into the larger and longer arteries of the legs.
"Drug-eluting stents approved for use today were designed with the coronary arteries in mind. Superficial femoral arteries in the leg present a different kind of anatomy that can be challenging to treat because re-obstruction of the vessel is a major concern," said Professor Johannes Lammer, Medical University of Vienna, Austria, and principal investigator for STRIDES. "The STRIDES trial is evaluating the use of a self-expanding stent system specifically designed to withstand normal leg movement, combined with the anti-proliferative drug everolimus, as a longer-term treatment alternative for patients with superficial femoral artery disease."
With its commitment to continuous innovation in treatments for vascular care, Abbott chose the stent used in STRIDES for its fracture-resistant design to withstand the substantial physical pressures exerted on the superficial femoral artery during normal leg movement. The system also features the drug everolimus, which is used in Abbott’s XIENCE™ V Coronary Stent System, and has been shown to reduce tissue growth in vessels following stent implantation. XIENCE V was launched in Europe and Asia Pacific in 2006. XIENCE V is currently an investigational device in the United States and Japan.
"Millions of people with PAD suffer from chronic leg and foot pain, and vascular disease is the leading cause of amputation worldwide,” said Chuck Foltz, vice president, Abbott Vascular. "Abbott’s STRIDES trial is designed to advance the development of new medical technology that has the potential to significantly improve the quality of life of these patients."
STRIDES is a single-arm clinical trial designed to enroll up to 100 patients at 14 European sites, with a primary endpoint of in-stent restenosis (a measure of vessel re-narrowing) in the superficial femoral artery at six months. Secondary endpoints include angiographic (X-ray) measurements of the change in vessel lumen diameter between the time immediately following stent placement and at 12 months, restenosis at 12 months, as well as five-year clinical follow-up to track resolution of PAD symptoms, limb preservation and patient survival.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products that are recognized internationally for their safety and effectiveness in treating patients with vascular disease.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.