This is a single center, non-randomized study. Patients will be treated with the sirolimus coated Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will have a repeat angiography at four months and will be followed for twelve months post-procedure.
This is a single center, non-randomized study of the Bx VELOCITY Balloon-Expandable Stent coated with sirolimus (140µg/cm2) and formulated for fast or slow release. The sirolimus coated stent is mounted on the Raptor OTW SDS. Approximately 30 patients with de novo or restenotic native coronary artery lesions \<=18mm in length and \>=3.0 to \>=3.5 mm in diameter by visual estimate who meet all eligibility criteria will be treated with the sirolimus coated Bx VELOCITY stent(s). Patients will be followed for five years post-procedure and will have a repeat angiography at 4 months, 12 months, 24 months, and 48 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Instituto Dante Pazzanese of Cardiology
São Paulo, Brazil
Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography.
Time frame: post procedure and 6 months
Assessment of lesion morphology by intravascular ultrasound (IVUS).
Time frame: post procedure and 6 months
Target vessel failure (TVF).
Time frame: 6 months
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