Paris, May 24th, 2018 – ANGIOLITE Trial 12-month results revealed at Euro PCR 2018
ANGIOLITE Trial 12-month results were presented for the first time at Euro PCR by Dr. J. Moreu Burgos at the “Clinical outcomes with new DES” session. The randomized prospective multicentric controlled trial enrolled 223 patients and had the objective of demonstrating Angiolite DES non inferiority versus Xience DES.
Both primary and secondary endpoints were met with statistical significance: 0.04mm Late Lumen Loss at 6 months, and 5.4% Target Lesion Failure (composite endpoint), 0.7% Binary Artery Restenosis (intra-stent), 0.7% definite thrombosis, as well as 6.4% MACE at 12 months.
6 months OCT results confirmed optimal struts coverage (90.8%) with only 64.3µm neointimal thickness, and very low malapposition (1.3%) despite high ratio of MI patients.
“Angiolite DES demonstrates a favorable early healing profile, long term efficacy and optimized deliverability”. Such outcomes are “positioning it as one of the most competitive DES available on the market”, commented Dr. J. Moreu.
“We are happy to have those data confirming the safety and long-term efficacy of our innovative Angiolite DES. Further developments are on the way to continue to provide the best of technology to the patients – stated Lluis Duocastella, CEO of iVascular.
The 24-month results of the ANGIOLITE Trial are expected to be presented at Euro PCR 2019.