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.
