Micell Technologies has completed patient enrollment in its DESSOLVE II CE Mark clinical study of the MiStentR drug-eluting coronary stent system. The MiStent DES is an ultra-thin drug-eluting stent distinguished by a rapid-absorbing drug/polymer coating formulation. Enrollment of 183 patients across 26 study centers throughout Europe and New Zealand was accomplished ahead of schedule.
Based on results observed in the DESSOLVE I first-in-human trial, the sample size in the DESSOLVE II CE Mark study was reduced from 270 to 171 subjects.
The DESSOLVE II CE Mark trial is a multi-center study of patients with documented stable or unstable angina pectoris. The primary endpoint is superiority of the MiStent DES in minimizing in-stent late lumen loss at nine months, compared to Medtronic's EndeavorR Sprint DES, as measured by the angiography core laboratory in de novo lesions ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 30 mm length stent.
Arthur J. Benvenuto, chairman and chief executive officer of Micell, said, "The coating on the MiStent DES differs substantially from those associated with commercially available DES technologies. The coating is engineered to clear the stent within 45 to 60 days and provide controlled and sustained delivery of sirolimus over a period of months, while limiting vascular exposure to the polymer coating to less than 90 days. As a result, we expect the MiStent DES could optimize sirolimus therapy by reducing the risk of complications such as late stent thrombosis, while suppressing neointimal hyperplasia and related healing responses to arterial injury that lead to restenosis."