Coronary Artery Disease Clinical Trial
Official title:
Cynergy - The CYPHER-NEVO Registry. An Observational Registry, to Evaluate the Safety and Performance of the NEVO™ Sirolimus-eluting Coronary Stent in Routine Clinical Practice, and to Compare Its Safety and Performance With the CYPHER Select® Plus Sirolimus-eluting Coronary Stent (SES)
The purpose of this registry is to compare the safety and the performance of the NEVO™
Sirolimus-eluting Coronary Stent, once commercially available, to the CYPHER Select® Plus
Sirolimus-eluting Coronary Stent in complex subjects presenting with acute STEMI for primary
intervention, diabetes mellitus or multi vessel disease. The second purpose of this registry
is to evaluate the safety and performance of the NEVO™ Sirolimus-eluting Coronary Stent,
once commercially available and the CYPHER Select® Plus Sirolimus-eluting Coronary Stent in
complex subjects diagnosed with acute STEMI for primary intervention, diabetes mellitus
and/or multi vessel disease.
The data will be collected from subjects treated with commercially available product and
following routine clinical practice. Uniform, complete and accurate data will be collected
on the subject's medical history, peri-procedurally, during the index hospitalization, and
during follow-up.
The CYPHER Select® Plus Sirolimus-eluting Coronary Stent (SES) is a balloon-expandable
intracoronary 316L stainless steel stent with a coating that consists of a blend of
Sirolimus and polymers.
Sirolimus is a potent immunosuppressive agent which has been proven to prolong graft
survival in many animal models of transplantation. Sirolimus prevents both proliferation and
migration of smooth muscle cells (in vivo and in vitro) in graft and balloon injury models.
Furthermore, Sirolimus has been shown to be effective in reducing restenosis and the need
for repeat revascularization while demonstrating superior efficacy measures such as
angiographic late loss and binary restenosis.
The NEVO™ Sirolimus-eluting Coronary Stent is a cobalt-chromium alloy stent platform that
incorporates two unique features: reservoir technology, and a bioresorbable polymer which
prevents initial contact between the polymer and the vessel wall and chronic polymer
exposure. This design minimized initial tissue exposure to polymer, and also enables polymer
resorption within approximately three months.
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