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.
