Enrollment Underway in Boston Scientific's ASTI European Postmarket Registry Studying the Adapt Carotid Stent

September 27, 2010—Boston Scientific Corporation (Natick, MA) has announced the start of patient enrollment in the European ASTI  clinical postmarket registry, which is designed to evaluate the company's Adapt carotid stent and monorail delivery system in combination with the FilterWire EZ embolic protection system for the treatment of carotid artery disease.

According to the company, ASTI is a prospective, single-arm registry evaluating clinical outcomes in patients undergoing carotid intervention with the Adapt carotid stent at 10 centers in Europe. The primary endpoint is the rate of major adverse events at 30 days, which is defined as major stroke, minor stroke, death, and myocardial infarction. Secondary endpoints include the rate of ipsilateral stroke, target lesion revascularization, and in-stent restenosis.

The ASTI registry's principal investigator, Marc Bosiers, MD, enrolled the first patient. In Europe, the Adapt stent system received CE Mark approval earlier this year. It is not available for sale in the United States.

Boston Scientific stated that the Adapt carotid stent features thin struts and an innovative stent design that is engineered for enhanced flexibility in the carotid artery. The device incorporates a self-expanding, rolled nitinol sheet with the company's dynamic tapering technology, which is designed to adapt to varying carotid anatomies. This second-generation carotid stent also provides improved visibility and a closed-cell geometry that allows for more consistent lesion coverage.

“The design enhancements of the Adapt stent represent a significant innovation in carotid intervention,” commented Dr. Bosiers. “The Adapt stent offers superior deliverability and increased scaffolding of the vessel wall, which are critical attributes for carotid stents.”