Micell Technologies announced enrolment of its 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. This clinical investigation is being conducted to support CE mark approval of the company’s MiStent drug-eluting coronary stent (DES) system. Stefan Verheye, Middelheim Hospital, Antwerp, Belgium enrolled the first patient in the study.
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 optimise 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 randomised, multicentre study of approximately 270 patients who 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 ischaemia. The primary endpoint is superiority of MiStent DES in minimising in-stent late lumen loss at nine months, compared to Medtronic’s Endeavor drug-eluting stent, 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 revascularisation rates, the extent of stent coverage and re-endothelialisation, via optical coherence tomography, and endothelial function will be evaluated in a subgroup of patients at nine months.
“Drug-eluting stents have significantly improved and expanded our ability to treat coronary atherosclerotic lesions compared to bare-metal stents,” said William Wijns, Cardiovascular Centre, 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 drug-eluting stents non-erodible polymers. Given the relatively short residence time of polymer on the stent, MiStent 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 CEO of Micell, added, “The MiStent drug-eluting stent has the potential to uniquely combine safety and efficacy with excellent deliverability. If these important patient benefits are confirmed in clinical trials, the MiStent performance and safety would be highly differentiated from both current drug-eluting stent offerings and from drug-eluting stent candidates known to be in development.”
The MiStent DES is an investigational device. It is not yet approved or available for sale in any market.
About the MiStent DES
The MiStent DES is a drug-eluting stent designed to optimize healing. The Company’s rapid-absorbing drug/polymer formulation is intended to precisely and consistently control drug elution and the duration of polymer exposure. As a result, the MiStent DES is intended to deliver a precise therapeutic solution for coronary artery disease with the potential to avoid the long-term safety concerns associated with current drug-eluting stents.
Using an approved drug (sirolimus) and polymer (PLGA), Micell’s patented supercritical fluid technology allows a carefully controlled drug/polymer coating to be applied to a bare-metal stent. Micell is leveraging the strengths of Eurocor’s (CE marked) Genius Magic Cobalt Chromium coronary stent system, a state-of-the-art bare-metal stent, shown to demonstrate excellent deliverability, conformability and flexibility. 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.