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Principal Investigator:
Daniel Lee, MD (Bay Med)
Sub-Investigators:
Stephen Mattichak, MD
Sponsor:
Medtronic, Abbott Vascular
Study
Purpose:
A Clinical Evaluation of the XIENCE™ V
Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects
with de novo Native Coronary Artery Lesions.
Objective:
To see if a new drug-coated stent
system is safe and effective in treating the narrowing of your heart artery.
The new drug-coated stent is the XIENCE™ V Everolimus Eluting
Coronary Stent System (the “XIENCE V Stent”). The XIENCE V Stent will be
compared to a drug-coated stent that has been approved by the U.S. Food and Drug
Administration (“FDA”) for treating narrowed arteries. The approved
stent is the TAXUSÒ
EXPRESS2™ Paclitaxel-Eluting Coronary Stent (the “TAXUS Stent”).
If the next generation TAXUS stent is approved by FDA during the Study, the
newer TAXUS stent will be used for comparison.
Status:
Active enrollment
If you have any
questions, please feel free to contact the coordinators, and they will be happy
to answer any questions you have regarding this study.
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