Diab8 Randomized Trial Will Evaluate Alvimedica's Cre8 Evo DES in Patients With Diabetes
June 4, 2018—At the EuroPCR 2018 conference held May 22–25 in Paris, France, Alvimedica Medical Technologies announced the design of the company's Diab8 diabetic drug-eluting stent (DES) trial.
The Diab8 randomized controlled trial will enroll 3,040 patients at 55 centers. The trial is intended to demonstrate the superior efficacy at 1 year of Alvimedica's Cre8 Evo, a polymer-free amphilimus-eluting stent, versus everolimus-eluting stents in the percutaneous coronary intervention (PCI) treatment of coronary artery disease in diabetic patients. The Principal Investigator of the Diab8 trial is Professor Antonio Colombo, MD, with IRCCS San Raffaele Hospital in Milan, Italy.
In the company's announcement, Prof. Colombo commented, “Preliminary data regarding the efficacy of Cre8 in diabetic patients are very encouraging, and through the Diab8 trial we hope we will be able to prove the efficacy of this innovative DES, as it could provide an important milestone for diabetics and their PCI treatment.”
In February 2017, the company announced European CE Mark approval of the Cre8 Evo. The device allows controlled elution of amphilimus (a combination of sirolimus and fatty acid) through its abluminal reservoir technology. Cre8 Evo is designed to provide effective drug concentration within the vessel wall including complex coronary anatomies and pathologies like those of diabetic patients. The very thin cobalt chromium body is sealed by the company's bioinducer surface to provide hemocompatibility and biocompatibility, increasing the rate of strut coverage and thus potentially reducing thrombogenicity, stated Alvimedica.