News | Stents Drug Eluting | January 08, 2016

Stentys Completes Enrollment of MiStent Randomized Trial Against Xience

DESSOLVE III clinical trial enrolled 1,400 “all-comers” patients, with primary endpoint of non-inferiority comparison of target lesion failure

January 8, 2016 — In December, Stentys announced completion of patient enrollment in DESSOLVE III. The 1,400-patient randomized clinical trial will compare the MiStent SES sirolimus eluting absorbable polymer coronary stent system to Abbott’s Xience stent.

The MiStent SES is a balloon-expandable stent designed to improve long-term clinical outcome of patients treated with conventional “workhorse” stents. The device features Crystalline Sirolimus technology, where thousands of microscopic drug crystals slowly dissolve in the surrounding tissue after absorption of the polymer carrier. This allows for a gradual, linear and much longer elution of sirolimus than with other competitive stents, hence reducing vessel over-scarring.

With 2 percent re-intervention rate (target lesion revascularization) at three-year follow-up in previous clinical trials, MiStent SES was shown to be superior to Xience in a retrospective propensity analysis presented by Alexandra Lansky, M.D., New Haven, Conn., during the last EuroPCR conference in Paris.

DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multi-center study comparing clinical outcomes between MiStent SES and Xience in a “real world, all-comers” patient population of 1,400 patients in 20 hospitals in Europe. Patients in the trial suffered from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia or acute coronary syndrome, and qualified for percutaneous coronary interventions. The primary endpoint is a non-inferiority comparison of target lesion failure (TLF) of the MiStent SES group versus the Xience group at 12 months post-procedure.

MiStent SES has already received CE Marking. Stentys is MiStent exclusive distributor worldwide, except in the United States, Canada, China, South Korea and Japan, and is currently conducting a controlled launch in select countries in Europe, Middle East and Asia.

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