Medinol announces completion of enrollment in its EluNIR HIGH BLEEDING RISK (HBR) trial. A prospective, multi-center, single-arm, open-label post marketing clinical trial, to assess the safety and efficacy of the EluNIR Drug Eluting Stent (DES) in combination with shortened DAPT duration, in patients undergoing PCI who are considered to be at high bleeding risk.
The EluNIR-HBR trial enrolled 316 patients across 18 sites in the UK and Israel, to collect and analyze data on the safety and efficacy of shortened DAPT duration (30 days in stable patients and up to 90 days in ACS patients) undergoing PCI using the EluNIR DES.
The Primary endpoint of the EluNIR-HBR study is a composite of cardiac death, myocardial infarction or stent thrombosis at 1 year (ARC definite and probable).
“The EluNIR-HBR study will allow us to determine the optimal duration of DAPT following PCI among this group of complex patients”, said Medinol’s Chief Scientific Officer, Yoram Richter, PhD., “and to further confirm the benefits of the exceptional healing characteristics that EluNIR can offer to HBR patients”.
EluNIR is Medinol’s sixth generation coronary stent featuring the unique WiZeCell™ stent design which minimizes strut dimensions leading to the lowest possible metal footprint. Combined with a spatially optimized drug delivery, the EluNIR stent is designed to promote rapid vascular healing. In the pivotal more-comers BIONICS study which recruited 1919 patients, this resulted in an exceptionally low late stent thrombosis rate of 0% at one year.