The main objective of this study is to demonstrate the superiority or non-inferiority of the sirolimus-eluting Bx VELOCITY® stent compared to intravascular brachytherapy in patients with in-stent restenotic native coronary artery lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
384
Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
Brachytherapy
Mayo Clinic Rochester
Rochester, Minnesota, United States
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 9 months post-procedure.
Time frame: 9 months post-procedure.
Angiographic in-lesion and in-stent binary restenosis (³ 50% diameter stenosis) at 6 months post-procedure (by QCA).
Time frame: 6 months post-procedure
Post-procedure and six-month in-stent and in-lesion percent diameter stenosis (%DS) and late loss at 6 months post-procedure (by QCA) - [analysis at 6 months chosen so that results from the GAMMA Trial can be used].
Time frame: 6 months post-procedure
Post-procedure and six-month in-stent and in-lesion minimum lumen diameter (MLD) (by QCA).
Time frame: Post-procedure and at six-month
Target lesion revascularization (TLR) at 6 and 9 months post-procedure.
Time frame: 6 and 9 months post-procedure
Target vessel revascularization (TVR) at 6 and 9 months post-procedure.
Time frame: 6 and 9 months post-procedure
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-proce
Time frame: 30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-procedure
Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of patients conducted at 5-7 investigational centers.
Time frame: post-procedure and six months
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Cost associated with the index hospitalization, length of stay, and repeat hospitalizations during the 12 mo post-procedure follow-up.
Time frame: 12 mo post-procedure
Rate of late thrombosis
Time frame: Throughout study