Boston gains green-light for pivotal stent trial:
This article was originally published in Clinica
Boston Scientific has begun a pivotal trial of its paclitaxel-coated stent in the US, after gaining go-ahead from the FDA. The prospective, randomised, double-blind TAXUS IV trial, which will involve over 1000 patients at 80 sites, will assess the safety and efficacy of a slow-release formulation of the drug-eluting stent as a treatment for coronary restenosis. The trial data will form the basis for a marketing application in the US.