The objective of this study is to assess the performance and safety of a sirolimus-eluting, heparin-coated, cobalt chromium balloon-expandable stent (Small Vessel Stent) in patients with de novo native coronary artery lesions in small vessels as compared to historical data from small vessel patients in the RAVEL trial receiving the Sirolimus-eluting Bx VELOCITY™ stent.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
The primary endpoint is in-stent late loss as measured by quantitative coronary angiography (QCA) at 6 months post-procedure.
Time frame: 6 months post-procedure
In-lesion late loss as measured by QCA at 6 months post-procedure.
Time frame: 6 months post-procedure
In-stent and in-lesion minimum lumen diameter (MLD) and percent diameter stenosis (%DS) by QCA post-procedure and at 6 months.
Time frame: Post-procedure and at 6 months
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.
Target Lesion Revascularization (TLR) at six and 12 months.
Time frame: 6 and 12 months
Target Vessel Revascularization (TVR) at six and 12 months.
Time frame: 6 and 12 months
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 12 months post-procedure.
Time frame: 30 days, 6 months and 12 months post-procedure
Stent Lumen and Stent Obstruction Volume by Intravascular Ultrasound (IVUS) at post procedure and six months follow-up.
Time frame: post procedure and six months
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