Double or Single Dose Sirolimus-Eluting Stents in Diabetic 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 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.

Official Title
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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)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: CYPHER Sirolimus-Eluting Coronary Stent
* Device: CYPHER Sirolimus-Eluting Coronary Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be minimum 18 years of age; Patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months; 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; 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; The target vessel is 2.5 mm and 3.5mm in diameter (visual estimate); The target lesion is <30 mm in length (visual estimate) located in a native coronary artery; Target lesion stenosis is >50% and <100% (TIMI I) (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; Patients admitted for treatment of diabetic ketoacidosis > 2 times in the past six months (Brittle Diabetics); Ejection fraction 30%; Impaired renal function (creatinine > 2.0 mg/dL);

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 |
| --- | --- |
| Active Comparator: 1<br>Single-dose Sirolimus-Eluting Coronary stent | Device: CYPHER Sirolimus-Eluting Coronary Stent<br>* Single dose Sirolimus-Eluting coronary stent<br>* Other names: Cypher Bx Velocity;|
| Active Comparator: 2<br>Double-dose Sirolimus-Eluting Coronary stent | Device: CYPHER Sirolimus-Eluting Coronary Stent<br>* Double-dose Sirolimus-Eluting coronary stent<br>* Other names: Cypher Bx Velocity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure. |  | 6 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. |  | 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure | 
| Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. |  | 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure | 
| Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. |  | 30 days, 6 months, 12 months and 2, 3, 4 and 5 years 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. |  | During Index Procedure | 
| Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method. |  | During Index Procedure | 
| 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 | 
| In-stent and in-lesion binary restenosis (> 50% diameter stenosis) as measured by QCA at 6 months and 2 years. |  | 6 months and 2 years | 
| In-stent and in-lesion mean percent diameter stenosis (%DS) and minimal lumen. diameter (MLD) measured by QCA post-procedure and at 6 months and 2 years. |  | post-procedure and at 6 months and 2 years | 
| In-lesion late lumen loss measured by QCA at 6 months and 2 years. |  | 6 months and 2 years | 
| Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and 6 months and 2 years. |  | post-procedure 6 months and 2 years. | 
| Glycemic control as measured by HbA1c at baseline, 6, 12, and 24 months. |  | baseline, 6, 12, and 24 months | 
| C-reactive protein levels measured at baseline, 6, 12, and 24 months related to patient outcomes. |  | baseline, 6, 12, and 24 months |