The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions.

E-Sirius Study: a European, Multi-Center, Randomized, Double-Blind Study of the Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions

The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent. Both stents are mounted on the Raptor® Rapid Exchange Stent Delivery System.

This is a multicenter (up to 35 centers), prospective, randomized double blind study. This study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated Bx VELOCITY stent to the uncoated Bx VELOCITY stent, both mounted on the Raptor Rapid Exchange Stent Delivery System. A total of 350 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be either randomized to the sirolimus coated or uncoated BX-VELOCITY stent. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with all patients undergoing repeat angiography at 8 months. Medical resource use during the 5 years follow-up period will be collected and analyzed.

Inclusion Criteria:

1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR patients with documented silent ischemia;
2. Treatment of a single de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
3. Target vessel diameter at the lesion site is >=2.50mm and <=3.0mm in diameter (visual estimate);
4. Target lesion is >=15mm and <=32mm in length (visual estimate);
5. Target lesion stenosis is >50% and <100% (visual estimate);

Exclusion Criteria:

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
2. Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction;
3. Unprotected left main coronary disease with >=50% stenosis;
4. Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
5. Have an ostial target lesion;
6. Angiographic evidence of thrombus within target lesion;
7. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
8. Documented left ventricular ejection fraction <=25%;