Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions

A Randomized Feasibility Study of the Double Dose or Single Dose Sirolimus-Eluting BX VELOCITY Balloon-Expandable Stent for the Treatment of Diabetic Patients With de Novo Native Coronary Artery Lesions(3D)

The main objective of this study is to assess safety and effectiveness of double dose sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary lesion, as compared to single dose sirolimus-eluting Bx VELOCITY™ stents.

Inclusion Criteria:

1. The patient must be minimum 18 years of age;
2. Patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months;
3. 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-III) OR patients with documented silent ischemia;
4. Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target lesions are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
5. The target vessel is 2.5 mm and 3.5mm in diameter (visual estimate);
6. The target lesion is <30 mm in length (visual estimate) located in a native coronary artery;
7. Target lesion stenosis is >50% and <100% (TIMI I) (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. Patients admitted for treatment of diabetic ketoacidosis > 2 times in the past six months (Brittle Diabetics);
3. Ejection fraction 30%;
4. Impaired renal function (creatinine > 2.0 mg/dL);