Coronary Artery Disease Clinical Trial
Official title:
A Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the ZoMaxx Drug Eluting Coronary Stent System Compared to the TAXUS™ Express2 Paclitaxel-Eluting Coronary Stent System in de Novo Coronary Artery Lesions
The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx drug-eluting stent in patients with blockage of native coronary arteries. The study is designed to demonstrate non-inferiority to the TAXUS Express2 Paclitaxel-Eluting Stent that has proven superior to bare metal stents and is a recognized standard of care.
Heart disease is the leading cause of death in Europe as a whole, and while mortality rates
for cardiovascular disease have decreased in most western European countries, due to
expanded use of prevention strategies and better treatment, coronary heart disease mortality
in the middle age groups is increasing rapidly in most of the countries in Eastern Europe.
The number of procedures performed to treat cardiovascular disease in Europe is constantly
increasing, although different types of procedures are exhibiting different trends.
Percutaneous coronary interventions (PCI) procedures, for example, totaled 430,000 in the
European Union (15 countries) and 520,000 in Europe as a whole (33 countries) in 2000, as
reported by the Euro Heart Survey, and growth is continuing at a rate of more than 20% per
year. Despite the effectiveness of intracoronary stents in maintaining a larger luminal
diameter as compared to angioplasty alone, 15 - 35% of in-stent restenosis occurs within 6
to 9 months after stent placement. While stents can reduce restenosis by blocking vascular
recoil and remodeling, mechanical intervention alone is incapable of treating the biological
problem of neointimal hyperplasia. Various approaches have been used to treat in-stent
restenosis, including balloon angioplasty, repeat stenting, rotational and directional
atherectomy, laser and local use of radiation at the time of stenting (brachytherapy).
However, these techniques add complexity to the interventional procedure and have not had
documented success in preventing restenosis. Drug-eluting stents (DES) using
antiproliferative agents delivered via a polymer based stent platform have shown significant
success in the reduction of restenosis in de novo lesions over the traditional bare metal
stents in randomized clinical trials. Local delivery of the pharmacological agent allows for
controlled delivery of high drug concentrations to the targeted tissue while maximizing
systemic drug effects. The ZoMaxx I Trial is a study of the ZoMaxx Drug Eluting Coronary
Stent System (ZoMaxx DES) to evaluate the potential benefits of the local application of the
zotarolimus drug in combination with a phosphorylcholine (PC)-coated tri-metal stent.
ZoMaxx™ Drug-Eluting Stent System is an Investigational device. Limited by Federal (U.S.)
law to investigational use only.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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