Enrollment Begins for Stentys’ APPOSITION II

December 4, 2009—Stentys, Inc. (Princeton, NJ) announced the commencement of enrollment in the APPOSITION II clinical study, which is a randomized trial comparing the Stentys self-expanding stent with a conventional balloon-expandable stent in acute myocardial infarction (AMI) patients. The study’s primary endpoint is stent strut apposition at day 3 postprocedure via extremely high-resolution optical coherence tomography (OCT) imaging. Stefan Verheye, MD, PhD, is principal investigator of APPOSTION II, and Professor Christian Spaulding, MD, PhD, enrolled the study’s first patient at the Cochin Hospital, Descartes University in Paris.

According to the company, the self-expanding feature of the Stentys platform is designed to ensure optimal apposition of a stent in the critical initial hours and days after an AMI procedure by being continuously applied to the vessel’s internal surface even during thrombus and vessel spasm relief—thereby avoiding malapposition.

"The first APPOSITION II case went extremely well," commented Professor Spaulding. "Three days later, thrombus and spasm had resolved, and the stent was perfectly apposed under OCT. This represents a breakthrough for successfully treating AMI."