NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions

Study Overview
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Brief Summary
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The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.

Official Title
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A Multicenter, Non-Randomized Study of the CYPHER NxT Sirolimus-Eluting Coronary Stent on BX SONIC OVER-THE-WIRE (OTW) Stent Delivery System(SDS)for the Treatment of de Novo Native Coronary Artery Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female patients 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; Treatment of a single de novo target lesion in a major native coronary artery; Target lesion is 2.5 mm and 3.5 mm in diameter (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 remain above normal at the time of treatment; Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina; Significant (> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff; Documented Left ventricular ejection fraction 25%; Totally occluded vessel (TIMI 0 level); 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>CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System | Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)<br>* CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge | Procedure Success is defined as the final residual diameter stenosis < 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion | From post-procedure up to hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later | Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR). | From post-procedure up to 30 days | 
| Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge | Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR). | From post-procedure up to hospital discharge | 
| Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later | Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR). | From post-procedure up to 12 months |