The MiStent DES employs Micell’s proprietary supercritical fluid technology which applies a precisely controlled absorbable polymer – active drug (sirolimus) matrix onto a cobalt-chromium stent.
DESSOLVE II is a prospective, controlled, 2:1 unbalanced randomized, multi-center study of approximately 270 patients. Patients will be enrolled at 26 clinical sites in Europe, New Zealand and Australia. Candidates for the trial are patients with documented stable or unstable angina pectoris or ischemia.
The primary endpoint is superiority of MiStent DES in minimizing in-stent late lumen loss at nine months, compared to Medtronic’s Endeavor DES, as measured with angiography in treated de novo lesions ranging in diameter from 2.5 to 3.5mm and amenable to treatment with a maximum 23mm long stent.
Along with secondary clinical endpoints such as major adverse cardiac events and revascularization rates, the extent of stent coverage and re-endothelialization, via optical coherence tomography (OCT), and endothelial function (vasomotor response) will be evaluated in a subgroup of patients at nine months.
Micell chairman and CEO Arthur Benvenuto said the MiStent DES has the potential to combine safety and efficacy with deliverability. If these important patient benefits are confirmed in clinical trials, the MiStent DES performance and safety would be highly differentiated from both current DES offerings and from DES candidates known to be in development.