The Study to Compare Cypher Versus Cypher Select in Treating Cornary 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 CYPHER SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.

Detailed Description
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This is a multicenter (up to 10 sites), open, prospective, 2-arm, unbalanced, randomized study designed to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent as compared to the CYPHER™ Sirolimus-eluting Coronary Stent. A total of 100 patients will be entered in the study and will be randomized on a 2:1 basis to the CYPHER SELECT™ stent or the CYPHER™ stent. 100 patients with de novo native coronary artery lesions <23 mm in length and more than 2.5 to less than 3.5 mm in diameter by visual estimate who meet all eligibility criteria will be either randomized.

Official Title
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A Randomized Study With the CYPHER SELECT™ Sirolimus-Eluting Balloon-Expandable Coronary 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: Cypher Select
* Device: Cypher


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-III) OR patients with documented silent ischemia; Single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent up to 23mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions are successfully treated before the target lesion; Target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate); Target lesion is located in a native coronary artery with a maximum lesion length that can be adequately covered by a single 23 mm stent; Target lesion stenosis is > 50% and < 100% (visual estimate). Exclusion Criteria: A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal; Unprotected left main coronary disease with more than 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; Calcified lesions which cannot be successfully predilated; Ejection fraction less than 30%; Totally occluded vessel (TIMI 0 level); Direct Stenting;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CYPHER SELECT™ Sirolimus-eluting Coronary Stent | Device: Cypher Select<br>* CYPHER SELECT™ Sirolimus-eluting Coronary Stent<br>* Other names: PTCA;|
| Active Comparator: 2<br>CYPHER™ Sirolimus-eluting Coronary Stent | Device: Cypher<br>* CYPHER™ Sirolimus-eluting Coronary Stent<br>* Other names: PTCA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic in-stent late loss |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent mean percent diameter stenosis |  | anytime post-procedure | 
| In-target vessel segment MLD |  | 6 months | 
| In-stent MLD |  | 6 months | 
| Target Lesion Revascularization (TLR) |  | 6 months | 
| Target Vessel Revascularization (TVR) |  | 6 months | 
| Major Adverse Cardiac Events (MACE) |  | 30 days, 6 and 12 months | 
| In-stent volume of restenosis determined by IVUS |  | 6 months |