Cordis Corporation (Cordis), is palnning to complete the clinical trial entitled “A Prospective, Single-Blind, Randomized, Multi-Center Study Comparing the CYPHER ELITE to the CYPHER Bx VELOCITY Sirolimus-Eluting Stent Systems (ELITE)” for the product CYPHER ELITE by June 2015. The main purpose of the study is to show similar (non-inferior) safety and effectiveness between CYPHER ELITE and CYPHER Bx VELOCITY Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for the treatment of de novo native coronary lesions. The study is being conducted in US.
The treatment, randomized, single blind (subject), parallel assignment, safety/efficacy study is currently ongoing, but not recruiting participants. The study will enroll approximately 1770 participants. The study director is H. Wayne Hutman, MD from Cordis Corporation.
Cypher Elite Stent is intended to reduce in-stent restenosis. It provides a scaffold to open the artery and a unique anti-rejection-type medication, sirolimus that helps to limit the overgrowth of normal cells while the artery heals. The stent reduces the chances of re-blockage in the treated area. It is provided with a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel wall and impedes the process of neointimal hyperplasia, thereby significantly reducing the incidence of in-stent restenosis.