The main objective of this study is to assess in-stent late lumen loss in diabetic patients with de novo native coronary lesions using the sirolimus-eluting Bx VELOCITYä stent as compared to the Bx VELOCITY balloon-expandable stent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
83
Foundation for Cardiovascular Medicine
La Jolla, California, United States
Florida Hospital
Orlando, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
In-stent late lumen loss as measured by QCA at six months post-procedure. In-stent measurement is defined as the measurement within the stented segment.
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 and 1 year post-procedure
Time frame: at 30 days, 6 months and 1 year post-procedure
Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 30 days, 6 months and 1 year post-procedure
Time frame: at 30 days, 6 months and 1 year post-procedure
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 30 days, 6 months and 1 year post-procedure
Time frame: at 30 days, 6 months and 1 year 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: Throughout study
Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method
Time frame: Throughout study
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: Throughout study
In-stent mean percent diameter stenosis (%DS), Binary restenosis and late lumen loss as measured by quantitative coronary angiography at post-procedure and at 6-months
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St Luke's Hospital
Kansas City, Missouri, United States
Queen Mary Hospital
Hong Kong, China
Batra Hospital & Research Centre
New Delhi, National Capital Territory of Delhi, India
Apollo Hospital
Chennai, Tamil Nadu, India
Jaslok Hospital & Research Centre
Mumbai, India
Escorts Heart Institute & Research Centre
New Delhi, India
National Heart Institute
Kuala Lumpur, Malaysia
...and 1 more locations
Time frame: at post-procedure and at 6-months
In-lesion mean percent diameter stenosis (%DS), mean lumen diameter (MLD), binary restenosis and late lumen loss as measured by quantitative coronary angiography at post-procedure and at 6-months
Time frame: at post-procedure and at 6-months
Glycemic control as measured by HbA1C at 6 months and 1 year follow-up
Time frame: at 6 months and 1 year follow-up