Tuesday, November 15, 2011
AHI Announces First Enrollment in Randomized Study for P.A.D.
Research study evaluates safety and effectiveness of new, experimental treatment designed to
reduce new blockages cause by scar tissue.
PHOENIX (November 15, 2011) – Arizona Heart Institute announces enrollment in an approved study to evaluate the safety and efficacy of a treatment for peripheral arterial disease (PAD) designed to reduce the occurrence of in-stent restenosis (ISR), a condition caused by the re-narrowing of blockages previously treated with a stent that may become so significant as to require additional procedures.
The EXCITE ISR Study (EXCImer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis) will compare the safety and efficacy of excimer laser atherectomy utilizing the Spectranetics’ Turbo-Tandem and Turbo Elite products in conjunction with balloon angioplasty, with that of balloon angioplasty alone in a 2:1 fashion on patients with femoropopliteal in-stent restenosis (ISR) development of scar tissue within a previously implanted nitinol stent in the arteries located at or above the knee. There is currently no medical device cleared by the FDA to treat patients with peripheral arterial ISR. The Sponsor, Spectranetics, is the first to support a clinical investigation for a treatment for ISR. Spectranetics manufactures a variety of medical devices for the treatment of cardiovascular disease.
Dr. Grayson Wheatley III, cardiovascular surgeon with the Arizona Heart Institute and Arizona Heart Hospital, is the Principle Investigator for the EXCITE ISR Study. EXCITE ISR will enroll up to 353 patients at up to 30 sites in the U.S, including up to 27 patients enrolled locally at the Arizona Heart Institute.
“Effective treatment for in-stent restenosis in the femoropoliteal arteries has yet to be proven in a scientifically rigorous randomized trial,” according to Dr. Wheatley. “The intent of this trial is to provide evidence for laser atherectomy in this difficult patient population, and I am looking forward to initiating this landmark clinical trial.”
The primary safety endpoint will measure major adverse events defined as death, major target limb amputation and target lesion revascularization (TLR) through 30 days following the procedure. The trial’s primary efficacy endpoint is freedom from clinically-driven TLR (re-intervention), which will be evaluated at six months following the procedure. These results will be included in a 510k filing with the FDA.
Peripheral Arterial Disease, or poor circulation of the legs, is a serious cardiovascular condition that causes arteries in the legs to become restricted or completely blocked. An estimated 10 million Americans experience this condition, with up to 50% showing no symptoms and only 10% having the classic symptom of claudication. Those suffering from PAD are at increased risk for heart disease, aortic aneurysms, stroke, amputation, and death. Treatments for PAD include exercise programs, medications, and minimally invasive endovascular procedures such as laser atherectomy, balloon angioplasty and stenting to improve circulation of the legs. A frequent complication of stenting is re-narrowing of the artery or in-stent restenosis (ISR). ISR is caused by the body’s response to the stent implantation, resulting in excessive scar tissue formation extending into the opening of the artery. Depending on the stent type, location, size, and number of stents implanted, ISR occurs in 18% to 50% of patients in the first year. Evidence also shows that patients who experience ISR are more likely to experience it in the future even after an additional procedure.
About Arizona Heart Institute
Arizona Heart Institute (AHI), an affiliate of Abrazo Medical Group, is among the world’s leading providers of cardiovascular care. Founded in 1971, AHI has earned its reputation for excellence by creating a state-of-the-art facility that specializes in the prevention, diagnosis and treatment of heart and blood vessel disease. Through dedication, education and innovation, AHI is leading the effort to eliminate cardiovascular disease and discovering new ways to save lives along the way. For more information, please visit www.azheart.com.
About Arizona Heart Hospital
Arizona Heart Hospital, a Campus of Phoenix Baptist Hospital, is a 59-bed regional center of excellence dedicated exclusively to cardiac and cardiovascular care. The hospital’s innovative patient-centered approach organizes teams of physicians, nurses, and support services around patients’ needs, offering significant enhancements in the ability to deliver excellent care at lower costs. For more information, please visit www.azhearthospital.com.
About the Sponsor, Spectranetics
Spectranetics develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system. The Company’s products are sold in 40 countries throughout the world and are used to treat arterial blockages in the heart and legs as well as the removal of pacemaker and defibrillator leads.
The Company’s Vascular Intervention (VI) products include a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. The Company also markets aspiration and thrombectomy catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages. The Lead Management (LM) product line includes excimer laser sheaths and cardiac lead management accessories for the removal of pacemaker and defibrillator cardiac leads.
For more information, visit www.spectranetics.com.