Atrium Medical Corporation is pleased to announce that the final patient was recently enrolled in the iCAST™ Atrium Registry Ultrasound Study (iCARUS). This study is a prospective, multi-center clinical trial studying the safety and efficacy of the Atrium iCAST™ Balloon Expandable Covered Stent in patients with occlusive disease of the iliac artery. Atrium's proprietary "balloon expandable" covered stent clinical study is approved by the FDA under an investigational device exemption (IDE).
Iliac artery occlusive disease is one form of Peripheral Arterial Disease (PAD). PAD affects over 8 million people in the United States. Patients with PAD typically present with symptoms of intermittent upper and lower leg pain, commonly known as "claudication" or "rest pain". Claudication is a sharp cramp- like pain in the legs that occurs during and after periods of walking or exercise. Rest pain is defined as "continued pain" or "painful cramping" of the legs immediately following exercise or when a patient is resting. Lower extremity leg pain is often caused by decreased blood flow to areas of the leg which is due to a narrowing or thrombotic occlusion of peripheral blood vessels. This blood vessel narrowing can also be a result of atherosclerosis (build up of plaque and cholesterol) along the luminal walls of leg arteries, including the common iliac, external iliac, femoral and popliteal vessels.
In this important PAD study, the small profile Atrium iCAST™ Covered Stent is used to re-open occlusive or narrowing conditions common to diseased iliac arteries which feed blood flow to the legs from the aorta. This landmark study, headed by Dr. John R. Laird, principal investigator from UC Davis Vascular Center in Sacramento, CA, is designed to study patients who present symptoms of occlusive iliac artery disease. "I am thrilled that we have completed enrollment in the iCARUS Trial," Laird noted. "This is an important study that will help define the role of the iCAST™ covered stent for the treatment of iliac occlusive disease." The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization or restenosis (by ultrasound determination) within 9 months post-procedure. Data generated from this landmark clinical study, along with other global clinical trials investigating the superiority of Atrium's novel "balloon expandable" covered stent technology, has the potential to change the standard of care for the treatment of PAD in complex iliac lesions, thereby improving the quality of care for those millions of PAD patients who suffer from both acute and chronic leg pain derived from occlusive iliac disease.
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