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November 22, 2009
INDUSTRY NEWS: Atrium's iCARUS Trial Reaches Enrollment Milestone
November 23, 2009—Atrium Medical Corporation (Hudson, NH) announced that the 100th patient was enrolled in iCARUS (iCast Atrium Registry Ultrasound Study). The iCARUS study is a prospective, multicenter clinical trial studying the safety and efficacy of the Atrium iCast balloon-expandable covered stent in patients with occlusive disease in the iliac artery. It is currently approved to treat tracheobronchial strictures. The iCast device is a polytetrafluoroethylene-film-encapsulated stainless steel stent that is premounted onto a low-profile balloon catheter, which is compatible with a 0.035-inch guidewire.
In the study, the iCast stent is used to reopen a narrowing in the diseased iliac artery. The iCARUS study is designed to enroll 225 patients (at 25 centers) who present with symptoms of iliac artery occlusive disease. The primary endpoint is the incidence of target lesion revascularization and restenosis at 9 months and 30-day death rates. John R. Laird Jr, MD, is the primary investigator for iCARUS.
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