The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus

Study Overview
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Brief Summary
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The main objective of this study is to compare the performance of the Cypher sirolimus-eluting and the Taxus paclitaxel-eluting stent systems in a prospective, multi-center, randomized clinical study.

Detailed Description
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This is a prospective, randomized study conducted at 90 centers in Europe, Latin-America and Asia. A total of 1335 patients will be entered into the study and will be randomized on a 1:1 basis to either the sirolimus-eluting or the paclitaxel-eluting stent system. All patients will have repeat angiography at eight months and will be followed for 24 months post-procedure.

Official Title
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A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Cypher Sirolimus-Eluting Stent
* Device: Taxus Paclitaxel-Eluting Stent


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; Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries; Ostial lesions; Bifurcations; Target vessel diameter of both lesions must be >=2.25mm and <=3.0mm in diameter (visual estimate); One target lesion must be at least 15 mm in length and the second lesion has to be at least 10 mm in length with no upper limit on either; Target lesion stenosis for both lesions 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 72 hours and the CK and CK-MB enzymes remain above normal at the time of treatment; Has unstable angina classified as Braunwald A I-II-III; Any of the lesions is an unprotected left main coronary disease with >=50% stenosis; Angiographic evidence of thrombus within target lesion; Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated (applies to both lesions); Documented left ventricular ejection fraction <=25%; 8. Totally occluded vessel (TIMI 0 level) (applies to both lesions); 9. Prior stent within 10mm of target lesion (applies to both lesions).

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cypher Sirolimus-Eluting Stent|nan|
|Device: Taxus Paclitaxel-Eluting Stent|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of the study is angiographic in-lesion binary restenosis rate at 8 months follow-up as determined by QCA. |  |  |