DURHAM, N.C., July 26, 2011 /PRNewswire/ -- Micell Technologies, Inc. today announced that it has completed patient enrollment in its DESSOLVE II CE Mark clinical study of the MiStent® 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.
Micell previously announced that, 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.
"We believe that by exceeding the projected enrollment rate for this study and completing enrollment in just 5 months, participating clinicians have demonstrated their enthusiasm for the novel MiStent drug-eluting stent," commented Dennis J. Donohoe, M.D., Micell's Chief Medical Advisor. "We extend our gratitude to the investigators and in particular the principal investigators of the study, William Wijns, M.D. and John Ormiston, M.D., for their support throughout the enrollment phase of this important trial."
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 Endeavor® 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