Boston Scientific completes clinical trial enrollment
Boston Scientific has completed patient enrollment in the ASTI post-market clinical follow-up study designed to evaluate its Adapt Monorail Carotid Stent System in combination with its FilterWire EZ Embolic Protection System for treatment of carotid artery disease in patients at high risk for carotid surgery.
The trial began in 2010 and has reached its enrollment goal of 100 patients at 11 sites in Europe. Principal Investigator of the study is Marc Bosiers, M.D., head of the department of vascular surgery, A.Z. Sint-Blasius Hospital in Dendermonde, Belgium.
The Adapt Carotid Stent features thin struts and an innovative design engineered for flexibility in the carotid arteries. It incorporates a self-expanding, rolled nitinol sheet with patented Dynamic Tapering Technology designed to conform to varying carotid anatomies. This second-generation carotid stent also provides excellent visibility and has a closed-cell geometry that facilitates consistent lesion coverage. It has been sold in Europe as well as other select countries since receiving CE Mark in 2010.
The study will examine rates of major adverse events such as death, stroke or myocardial infarction at 30 days. It will assess rates of late ipsilateral stroke, target lesion revascularization and in-stent restenosis.
In the U.S., the Adapt Carotid Stent System is not available for sale.