BALTON Ltd. (BALTON), a medical equipment company, is planning to complete trial entitled “Comparison of Safety and Efficacy of Drug Eluting Stents : TAXUS (Boston Scientific) vs. LUC-Chopin (Balton, Poland) Implanted Into Saphenous Vein Grafts. Study With Serial Intravascular Ultrasounds.” for Luc-Chopin 2 by June 2010. The purpose of the study is to compare safety and efficacy of implantation of two different types of stents eluting paclitaxel from stable vs biodegradable polymer (TAXUS stent vs LUC-CHOPIN stent) into coronary artery by-pass graft. The study is being conducted in Poland.
This phase III, randomized, single blind (subject), active control, parallel assignment, safety/efficacy study is currently recruiting approximately 50 participants. The principal investigator of the study is Adam R Witkowski, MD,PhD Institute of Cardiology, Warsaw, Poland.
Luc-Chopin 2 is a biodegradable polymer coated, paclitaxel coronary drug eluting stent. Luc-Chopin stent coating technology enables to obtain the most flexible layer of biodegradable polymer, paclitaxel carrier. The polymer layers release paclitaxel in time-controlled process of their slow biodegradation (lasting ca 6 weeks), inhibiting neointime formation process.