Primary Outcome Measures:
- The primary endpoint is in-lesion restenosis at 6 months post-procedure by QCA. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-proced [ Time Frame: 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
- Angiographic in-stent binary restenosis (50% diameter stenosis) 6 months post-procedure. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]
- In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]
- Target lesion revascularization (TLR) at 6 and 9 months post-procedure. [ Time Frame: 6 and 9 months post-procedure ] [ Designated as safety issue: Yes ]
- Target vessel revascularization (TVR) at 6 and 9 months post-procedure. [ Time Frame: 6 and 9 months post-procedure ] [ Designated as safety issue: Yes ]
- Target vessel failure (TVF) at 6 and 9 months post-procedure. [ Time Frame: 6 and 9 months post-procedure ] [ Designated as safety issue: Yes ]
This is a multicenter (approximately 10 - 14 sites), prospective, non-randomized study. The study is designed to evaluate the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in patients with de novo native coronary artery lesions. A total of 100 patients will be entered in the study. Patients who meet the eligibility criteria will be enrolled into the study. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4 and 5 years post-procedure, with all patients undergoing repeat angiography at 6 months. Approximately 50 patients will be required to have an intravascular ultrasound (IVUS) procedure at baseline and at the 6-month angiographic follow-up.