BARCELONA, Spain - Cordis Corporation will compare its CYPHER SELECT(TM) + (Plus) Sirolimus-eluting Stent with balloon angioplasty, the company announced today at the EuroPCR meeting in Barcelona. The multicenter, prospective, randomized ACHILLES study will evaluate the performance of stenting versus balloon angioplasty in patients with below-the-knee (infrapopliteal) peripheral artery disease (PAD).
Patients with PAD have plaque buildup in their arteries, limiting proper flow and delivery of blood and oxygen to different areas of the body. Ischemic infrapopliteal arterial disease, a type of PAD, limits blood flow below the knee, causing pain, skin ulcers or sores, and an increased risk of amputation.
Dierk Scheinert, M.D., Head, Department of Angiology, University of Leipzig - Heart Center & Park Hospital said, "Peripheral artery disease is a widespread but often under diagnosed condition in Europe and around the world. It is important to understand and evaluate the safety and efficacy of treating patients less invasively with a drug-eluting stent and angioplasty opposed to angioplasty alone as we explore potential new treatment options for below-the-knee PAD." Dr. Scheinert, is principal investigator of the ACHILLES study and has served as a consultant to Cordis Corporation. He conducted the first procedure when the study was initiated in March at the University of Leipzig - Heart Center & Park Hospital.
The ACHILLES study will be conducted in 17 centers throughout Europe. Two hundred patients with new (de novo) or restenotic native lesions in arteries below the knee (i.e., tibioperoneal, anterior, posterior tibial, or peroneal) will be entered into the study and randomized on a 1:1 basis to receive the CYPHER SELECT(TM) + (Plus) Stent or balloon angioplasty, the current endovascular standard of care. All patients will undergo an X-ray examination of the blood vessels (angiography) at 12 months to assess the primary study endpoint of re-narrowing or blockage (in-segment binary restenosis).
"The safety and efficacy of the CYPHER SELECT(TM) + (Plus) Stent in treating patients with arterial obstructions in arteries where regulatory approvals have been approved has been proven through a robust clinical trial program," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical Affairs, Cordis Corporation. "We are now eager to evaluate how this stent may in the future provide physicians and patients with a minimally invasive treatment option to open below-the-knee arterial blockages, which can be extremely painful and often lead to limb amputation."
About the CYPHER SELECT(TM) Plus Stent
The first next-generation drug-eluting stent, the CYPHER SELECT(TM) Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER SELECT(TM) + (Plus) Stent, the first third-generation drug-eluting stent, received the CE mark in June 2006 and is now available in many markets outside the United States.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease.