FIM-BR - First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent

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.

Inclusion criteria

• Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS) or a positive ischemia study;
• Single de novo or restenotic lesion requiring treatment in a major native coronary artery;
• Target lesion is <=18mm in length (visual estimate);
• Target lesion is >=3.0mm and <=3.5mm in diameter (visual estimate);
• Target lesion stenosis is >50% and <100% (visual estimate);

Exclusion criteria

• A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
• Unprotected left main coronary disease with >=50% stenosis;
• Have an ostial target lesion;
• Angiographic evidence of thrombus within target lesion;
• Calcified lesions which cannot be successfully predilated;
• Ejection fraction <=30%;
• Target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch);
• Totally occluded vessel;