Study of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With 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-eluting Bx VELOCITYTM stent in reducing in-lesion late loss in patients with de novo native coronary artery lesions.

Official Title
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A Multicenter, Non-Randomized Study of the 4.0mm Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: 4.0 CYPHER Sirolimus-Eluting Coronary 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 lesions treatable with 4mm stent (visual estimate); Target lesion is 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;

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: 4.0 CYPHER Sirolimus-Eluting Coronary Stent<br>* 4.0 CYPHER Sirolimus-Eluting Coronary Stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA. |  | 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 and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-proced |  | 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-procedure | 
| Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA. |  | 6 months post-procedure | 
| In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure. |  | 6 months post-procedure | 
| Target lesion revascularization (TLR) at 6 and 9 months post-procedure. |  | 6 and 9 months post-procedure | 
| Target vessel revascularization (TVR) at 6 and 9 months post-procedure. |  | 6 and 9 months post-procedure | 
| Target vessel failure (TVF) at 6 and 9 months post-procedure. |  | 6 and 9 months post-procedure | 
| Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of approximately 50 patients at selected centers. |  | post-procedure and six months in a subset of approximately 50 patients | 
| 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. |  | End of study | 
| Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method. |  | End of Study | 
| 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 |