Atrium's proprietary "balloon expandable" covered stent clinical study includes patients with lower extremity leg pain.
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 along the luminal walls of leg arteries, including the common iliac, external iliac, femoral and popliteal vessels.
In this 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. The 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 said, in a press release. “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 nine 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.
Atrium's proprietary Balloon Expandable Covered Stent technology is a micro-thin biomaterial film encapsulating a unique stainless steel slotted tube stent. Since it is pre-mounted by the company onto an extraordinary low profile balloon delivery catheter, this first-to-market technology offers single operator deployment through a very small diameter introducer sheath, without the need for surgery, which is common for conventional "stent graft technology."
The Atrium iCAST Balloon Expandable Covered Stent is currently an investigational device in the United States for the treatment of iliac artery disease and is currently FDA approved for the treatment of tracheobronchial strictures.
Source: Atrium Medical Corporation
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