The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study.

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 coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the bare metal Bx VELOCITY balloon-expandable stent. Both stents will be mounted on the Raptor Rapid Exchange Delivery Stent System.

Detailed Description
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This is a multicenter (19 sites), prospective, randomized study. This study has a 2 arm design assessing the safety and effectiveness of the sirolimus coated BxTM VELOCITY stent to the bare metal BxTM VELOCITY stent, both mounted on the Raptorâ Rapid Exchange Stent Delivery System. A total of 220 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be randomized to the coated or uncoated BX VELOCITY stent. Therefore, neither the Investigator nor the patient will know which stent will be implanted. Patients will be followed for twelve months post-procedure, with all patients having a repeat angiography at 6 months. An ancillary study with in-stent IVUS measurements at 6 months follow-up will be performed in all patients of 6 pre-selected clinical sites. It is assumed that these sites will enroll more than 90 patients.

Official Title
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A Randomized Study With the Sirolimus Coated Modified BX Velocity 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: Sirolimus coated Bx Velocity™
* Device: Bare metal Bx Velocity™


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 of 18mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment; Target lesion is >= 2.5 and <= 3.5mm in diameter (visual estimate); Target lesion is located in a native coronary artery which can be covered by one stent (single lesion); Target lesion stenosis is >50% and <100% (TIMI I) (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 >=50% stenosis; Have an ostial target lesion; Angiographic evidence of thrombus within target lesion; Calcified lesions which cannot be successfully predilated; Ejection fraction <=30%; Totally occluded vessel (TIMI 0 level); Target lesion involves bifurcation including a side branch >=2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting which is likely to occur if side branch is diseased and intended to be stented; Planned 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Bare metal Bx Velocity™ Balloon-Expandable Stent mounted on the Raptor® rapid exchange delivery system | Device: Bare metal Bx Velocity™<br>* bare-metal stent<br>|
| Experimental: 2<br>Sirolimus coated modified Bx Velocity™ Balloon-Expandable Stent mounted on the Raptor® rapid exchange delivery system | Device: Sirolimus coated Bx Velocity™<br>* drug-eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic in-stent late loss as determined by Quantitative Coronary Angiography. |  | 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent mean %DS by QCA |  | post-procedure | 
| In-target vessel segment MLD |  | 6 months | 
| In-stent MLD |  | 6 months | 
| Target Lesion Revascularization |  | 6 and 12 months; or 2, 3, 4 and 5 years | 
| Target Vessel Revascularization |  | 6 and 12 months; or 2, 3, 4 and 5 years | 
| Major Adverse Cardiac Events |  | 30 days; 6 and 12 months; or 2, 3, 4 and 5 years; | 
| Neo-intimal growth assessed by IVUS |  | 6 months |