To study the safety and efficacy of Atrium iCAST balloon expandable covered stent in patients with occlusive disease in the iliac artery
Atrium Medical has reported that the 100th patient was enrolled in its iCAST Atrium Registry Ultrasound Study (iCARUS). The 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 in the iliac artery.
This first of its kind premounted ‘balloon expandable covered stent’ US trial is approved by the FDA under an investigational device exemption.
In the study, the iCAST balloon expandable covered stent is being used to re-open a narrowing in the diseased iliac artery. This study, with Dr. John Laird as the primary investigator from UC Davis Vascular Center in Sacramento, CA, is designed to study 225 patients enrolled at 25 centers who present symptoms of iliac artery occlusive disease.
The primary endpoint of this study is the incidence of target lesion revascularization (TLR) and restenosis (amount of re-narrowing of the treated blood vessel) at 9 months and 30-day death rates. The 100th patient was enrolled by Dr. Heron Rodriguez at Northwestern Hospital in Chicago, IL.
Atrium’s proprietary balloon expandable covered stent is a PTFE film encapsulated stainless steel stent that is pre-mounted onto an extraordinary low profile balloon catheter. The covered stent balloon catheter delivery system is compatible with a 0.035 guidewire.