Ethos I stents are coated with slow-release and moderate-release formulations of 17 beta-estradiol, an approved drug used in hormone replacement therapy and other indications.
The trial is a three-center, randomized, double-blind, prospective study that will be followed by an open label phase during which patients will receive the optimal elution profile. The study will eventually include 150 patients once the optimal release formulation has been chosen.
The study is comparing the Ethos I drug eluting stent with a leading bare metal stent for the elimination of restenosis in patients eligible for balloon angioplasty with symptomatic ischemic heart disease due to discrete de novo and/or restenotic coronary artery lesions.
“Estradiol’s pro-healing properties are likely to provide the patient with a safer alternative to current treatments and also allow X-Cell to enter into the drug eluting stent space with a truly novel product,” said X-Cell medical president and CEO, Dr Oded Ben-Joseph.