Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)

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 VELOCITYTM stent in reducing target vessel failure in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITYTM balloon-expandable stent. Both stents are mounted on the Raptorâ over-the-wire (OTW) Stent Delivery System.

Detailed Description
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This is a multicenter (55 sites), prospective, 2-arm randomized, double-blind study designed to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent as compared to the uncoated Bx VELOCITYTM stent. A total of 1100 patients will be entered in the study and will be randomized on a 1:1 basis. Patients with de novo native coronary artery lesions >/=15mm and </=30mm in length and >/=2.50mm to </=3.5mm in diameter by visual estimate who meet all eligibility criteria will be either randomized to the sirolimus-coated Bx VELOCITYTM stent or the uncoated Bx VELOCITYTM stent. Patients will be followed at 30 days, 3, 6, 9 and 12 months, and 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with approximately 850 patients having repeat angiography at 8 months. A subset of approximately 17 centers will participate in an intravascular ultrasound (IVUS) sub study, in which all patients at these centers will be enrolled in the sub study. Additionally, data will be collected for a medical economic analysis. These data will include costs associated with the index hospitalization and length of stay, and rehospitalizations during the 12-month follow-up period. This is a single lesion treatment study. Patients who have had interventions of other lesions within 30 days of the study procedure or have interventions planned after the index procedure are excluded. It is anticipated that the total length of the study will be 101 months: 5 months to complete patient enrollment and 8 years for follow-up.

Official Title
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A Multicenter, Randomized, Double-Blind Study of the Sirolimus-Coated BX VELOCITYTM 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: CYPHER Sirolimus-Eluting Stent
* Device: Uncoated BX VELOCITY Balloon-Expandable Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female patients minimum 18 years of age 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; Target lesion is 2.50mm and 3.5mm in diameter (visual estimate); Target lesion is 15mm and 30mm 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, or is having a peri infarction; Documented Left ventricular ejection fraction 25%; Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment; Target lesion involves bifurcation including a diseased side branch 2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require treatment;

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>Cypher Bx Velocity | Device: CYPHER Sirolimus-Eluting Stent<br>* CYPHER Sirolimus-Eluting Stent<br>|
| Active Comparator: 2<br>Uncoated Bx Velocity | Device: Uncoated BX VELOCITY Balloon-Expandable Stent<br>* Uncoated BX VELOCITY Balloon-Expandable Stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 9 months post-procedure. |  | 9 months post procedure | 

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 target vessel revascularization at 30 dys and 3, 6, 9, and 12 mo, and 2, 3, 4, 5, 6, 7, and 8 yrs post-procedure; |  | 30 dys and 3, 6, 9, and 12 mo, and 2, 3, 4, 5, 6, 7, and 8 yrs post-procedure | 
| Angiographic binary restenosis (>/=50% diameter stenosis) 8 mo post-procedure; |  | 8 months post-procedure | 
| In-stent and in-lesion MLD at 8 mo post-procedure; |  | 8 months post-procedure | 
| Target lesion revascularization at 9 mo post-procedure; |  | 9 months post-procedure | 
| Target vessel revascularization at 9 mo post-procedure; |  | 9 months post-procedure | 
| Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used; |  | Study Completion | 
| Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method; |  | Study Completion | 
| Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay; |  | During the hospital stay | 
| Costs associated with the index hospitalization and length of stay, and repeat hospitalizations during the 12-month post-procedure follow-up period. |  | 12-month post-procedure |