Final Patient Enrolled for PAD Study


November 5, 2010

November 5, 2010 – The final patient has been enrolled in a trial studying a balloon-expandable covered stent for those with occlusive disease of the iliac artery. The iCARUS trial is investigating the iCast stent, made by Atrium Medical.

Iliac artery occlusive disease is one form of peripheral arterial disease (PAD). Patients with PAD typically have intermittent upper and lower leg pain, commonly known as “claudication” or “rest pain.” Lower extremity leg pain is often caused by decreased blood flow due to a narrowing or thrombotic occlusion of peripheral blood vessels. It can also be a result of atherosclerosis along the luminal walls of leg arteries, including the common iliac, external iliac, femoral and popliteal vessels.

In the study, the stent is used to re-open diseased iliac arteries, which feed blood flow to the legs from the aorta.

“I am thrilled that we have completed enrollment in the iCARUS trial,” said John R. Laird, M.D., U.C. Davis vascular center in Sacramento, Calif., and principal investigator of the study. “This is an important study that will help define the role of the iCast covered stent for the treatment of iliac occlusive disease.”

The iCast balloon-expandable covered stent is a micro-thin biomaterial film encapsulating a stainless steel slotted tube stent. Since it is pre-mounted by the company onto a balloon delivery catheter, it offers single-operator deployment through a very small diameter introducer sheath, without the need for surgery. The delivery system is compatible with 0.035-inch guidewires.

The stent is currently an investigational device in the United States and is currently FDA-approved for treating tracheobronchial strictures.

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