Enrollment Completed in OCT Study for Micell's MiStent SES

March 25, 2016—Micell Technologies, Inc. announced completion of enrollment in the optical coherence tomography (OCT) study of the company’s MiStent sirolimus-eluting absorbable polymer coronary stent system (MiStent SES). The study will compare changes in coronary arteries between 6 and 24 months following treatment with MiStent or the Xience V everolimus-eluting coronary stent system (Abbott Vascular). The clinical investigation and data analysis are being conducted by Cardialysis and the European Cardiovascular Research Institute in Rotterdam, The Netherlands.  

According to the company the OCT study will evaluate 60 patients randomized to MiStent or Xience. Previously, a MiStent clinical study has shown essentially no increase in late lumen loss between 6- and 18-month follow-up. Xience has demonstrated almost a doubling of late lumen loss in long-term follow-up. 

The company stated that this OCT study has the potential to show superiority of the MiStent SES against Xience, with significantly less progression of in-stent percent volume obstruction and frequency of neoatheroma formation over time. It is part of the larger DESSOLVE III study, which is a 1:1 randomized comparison of target lesion failure at 12 months for MiStent versus Xience in 1,400 patients. Results from DESSOLVE III are expected to be available in the first quarter of 2017.

In 2013, the MiStent SES received European CE Mark approval, which was supported by clinical data from the DESSOLVE I and DESSOLVE II trials. These trials demonstrated superior in-stent late lumen loss rates and an excellent safety profile. and is being distributed exclusively by Stentys around the world, with the exception of the United States, Canada, China, South Korea, and Japan. Stentys is currently conducting a controlled launch in select countries in Western Europe, the Middle East, and Asia.