The main objective of this study is to assess safety and effectiveness of double dose sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary lesion, as compared to single dose sirolimus-eluting Bx VELOCITY™ stents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Single dose Sirolimus-Eluting coronary stent
Double-dose Sirolimus-Eluting coronary stent
Institute Dante Pazzanese of Cardiology
São Paulo, Brazil
The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure.
Time frame: 6 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, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure.
Time frame: 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure
Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure.
Time frame: 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure.
Time frame: 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure
Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.
Time frame: During Index Procedure
Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method.
Time frame: During Index Procedure
Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay.
Time frame: During the hospital stay
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In-stent and in-lesion binary restenosis (> 50% diameter stenosis) as measured by QCA at 6 months and 2 years.
Time frame: 6 months and 2 years
In-stent and in-lesion mean percent diameter stenosis (%DS) and minimal lumen. diameter (MLD) measured by QCA post-procedure and at 6 months and 2 years.
Time frame: post-procedure and at 6 months and 2 years
In-lesion late lumen loss measured by QCA at 6 months and 2 years.
Time frame: 6 months and 2 years
Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and 6 months and 2 years.
Time frame: post-procedure 6 months and 2 years.
Glycemic control as measured by HbA1c at baseline, 6, 12, and 24 months.
Time frame: baseline, 6, 12, and 24 months
C-reactive protein levels measured at baseline, 6, 12, and 24 months related to patient outcomes.
Time frame: baseline, 6, 12, and 24 months