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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: sirolimus-coated Bx Velocity stent
* Device: uncoated Bx Velocity stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 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; Target vessel diameter at the lesion site is >=2.50mm and <=3.0mm in diameter (visual estimate); Target lesion is >=15mm and <=32mm in length (visual estimate); Target lesion stenosis is >50% and <100% (visual estimate); Exclusion Criteria: 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; Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction; Unprotected left main coronary disease with >=50% stenosis; Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff; Have an ostial target lesion; Angiographic evidence of thrombus within target lesion; Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated; Documented left ventricular ejection fraction <=25%;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>drug-eluting stent | Device: sirolimus-coated Bx Velocity stent<br>* drug-eluting stent<br>|
| Active Comparator: 2<br>bare-metal stent | Device: uncoated Bx Velocity stent<br>* bare-metal stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent minimum lumen diameter (MLD). |  | 8 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of MACE defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat TLR. |  | 1, 6, 9, and 12 months; 2, 3, 4, 5, 6, 7 and 8 years post procedure. | 
| Angiographic binary restenosis (>=50% diameter stenosis). |  | 8 months. | 
| In-lesion MLD. |  | 8 months. | 
| Target lesion revascularization. |  | 9 months. | 
| Target vessel revascularization. |  | 9 months. | 
| Target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. |  | 9 months. | 
| Device success (final residual diameter stenosis of < 50%). |  | any time post-procedure. |