Elixir Medical has initiated patient enrollment in Excella BD randomized clinical trial designed to evaluate the DESyne BD Novolimus Eluting Coronary Stent System (CSS) with bioabsorbable coating.
The Elixir DESyne BD stent combines a low drug dose (5µg/mm stent length) of internally developed macrocyclic lactone Novolimus, a metabolite of sirolimus, and a low polymer load of a polylactide-based bioabsorbable polymer resulting in polymer coated drug eluting stent (DES) system.
Excella BD is a randomized, single-blind, multi-center clinical trial designed to enroll 145 patients at 10 sites in Europe and Brazil and compares the DESyne BD CSS to the Medtronic Endeavor Zotarolimus Eluting CSS.
The primary endpoint of the trial is the in-stent late lumen loss at 6 months measured using quantitative coronary angiography (QCA) with an additional evaluation in a sub-set of patients by intravascular ultrasound (IVUS) at 6 months.
The clinical endpoint is based on a device-oriented composite endpoint defined as cardiac death, myocardial infarction not attributable to a non-interventional vessel and clinically-indicated target lesion revascularization.
Elixir Medical chief executive officer Motasim Sirhan said that they are excited to initiate this trial and the DESyne BD CSS is an important platform in their comprehensive portfolio of products designed to address patient and physician needs.