To evaluate the clinical safety, efficacy, and pharmacokinetics (PK) of the Endeavor Resolute Zotorolimus Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) between 2.5 and 3.5 mm in diameter.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
139
Initial implant of drug eluting stent (zotarolimus)
Monash Medical Centre
Melbourne, Australia
Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA)
Time frame: 9 months
Major adverse cardiac event (MACE) rate
Time frame: 30 days, 4, 6, 9 & 12 months
Acute success (device, lesion, and procedure)
Time frame: 4 or 9 Months
Target vessel failure (TVF)
Time frame: 9 months
Target lesion revascularization (TLR)
Time frame: 9 months
Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS)
Time frame: 4 or 9 months
Pharmacokinetic parameters
Time frame: last measurement at 60 days
Angiographic parameters (in-stent and in-segment)
Time frame: 4 or 9 months
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