Micell Technologies,™ Inc. today announced it has enrolled the first patient in the DESSOLVE II (DES with Sirolimus and a bioabsorbable pOLymer for the treatment of patients with de noVo lEsions in the native coronary arteries) clinical trial. Stefan Verheye, M.D., Ph.D. at Middelheim Hospital, Antwerp, Belgium enrolled the first patient in the study. This clinical investigation is being conducted to support CE Mark approval of the company’s MiStent™ Drug-Eluting Coronary Stent System (MiStent DES).
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. The polymer dissolves and releases the drug into the surrounding tissue in a controlled manner, designed to optimize dosing of the drug throughout the affected artery. In GLP pre-clinical trials, the drug completely elutes and the polymer is eliminated from the stent within 45 to 60 days in vivo, resulting in a bare-metal 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 3.5 mm and amenable to treatment with a maximum 23 mm 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. More information on the DESSOLVE II trial can be found at ClinicalTrials.gov.
“Drug-eluting stents have significantly improved and expanded our ability to treat coronary atherosclerotic lesions compared to bare-metal stents,” said William Wijns, M.D., Cardiovascular Center, Aalst, Belgium, and principal investigator of the study. “However, cardiologists are still looking for options to improve safety and outcomes. The MiStent DES may address some of these issues directly. Based on recent GLP animal data, the polymer and drug are gone from the stent within 45 to 60 days. This may reduce the risk of late-stent thrombosis related to long-term exposure to DES non-erodible polymers. Given the relatively short residence time of polymer on the stent, MiStent DES may allow for a shorter duration of dual anti-platelet therapy and be a safer choice for non-compliant patients. These performance-enhancing properties are what interventional cardiologists are looking for in a new drug-eluting stent.”
Arthur J. Benvenuto, Chairman and Chief Executive Officer of Micell, added, “The MiStent DES has the potential to uniquely combine safety and efficacy with excellent 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.”
Source : Micell Technologies Inc.