A Study of Diabetic Patients With De Novo Native 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 CYPHER sirolimus-eluting stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Both stents are mounted on the Raptorâ Rapid Exchange Stent Delivery System.

Detailed Description
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This is a multicenter (19 sites), prospective, 2 arm randomized study designed to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Patients with de novo native coronary artery lesions <= 42 mm in length and >=2.5mm and <=3.5mm in diameter (by visual estimate) will be included in the study. A total of 190 patients will be entered and randomly allocated to the CYPHERTM sirolimus-eluting stent or the uncoated Bx VELOCITY balloon-expandable stent at a 1:1 ratio. Patients will be followed for 12 months post-procedure, with all patients having a repeat angiography at 8 months (± 1 month). It is anticipated the total duration of the study will be 18 months: 6 months to complete patient enrollment and 12 months for follow up.

Official Title
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A German Multicenter, Randomized, Controlled, Open-Label Study of the Cypher Sirolimus-Eluting Stent in the Treatment of Diabetic Patients With De Novo Native Coronary Artery Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: CYPHER sirolimus-eluting stent
* Device: uncoated Bx VELOCITY balloon-expandable 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 I-II) OR patients with documented silent ischemia; Manifest diabetes mellitus, proven by fasting glucose (12 h) > 127 mg/dl or oral glucose challenge: >= 200 mg/dl after 2 h or diabetes mellitus already treated with oral antidiabetics or insulin; Treatment of a de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with 2- or more-vessel-disease can be enrolled if previous treatment(s) of those lesions other than the target lesion have taken place at least 3 months prior to the enrolment to this study. If more than 1 study stent is necessary to treat the lesion, overlapping is strongly recommended; Target vessel diameter at the lesion site is >= 2.5mm and <= 3.5mm (visual estimate); (stents will be available in 2.5 / 3.0 mm width); Target lesion is <= 42mm in length (visual estimate); (stents will be available in 8, 18 and 33 mm length); Target lesion diameter stenosis is > 50% and <100% (visual estimate); Exclusion Criteria: None

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CYPHER sirolimus-eluting stent | Device: CYPHER sirolimus-eluting stent<br>* drug-eluting stent<br>|
| Active Comparator: 2<br>uncoated Bx VELOCITY balloon-expandable stent | Device: uncoated Bx VELOCITY balloon-expandable stent<br>* bare metal stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angiographic in-segment late loss |  | 8 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late loss |  | 8 months post-procedure | 
| angiographic binary restenosis |  | 8 months post-procedure | 
| target lesion revascularization (TLR) |  | 8 months post-procedure | 
| target vessel revascularization (TVR) |  | 8 months post-procedure | 
| target vessel failure (TVF) |  | 8 months post-procedure | 
| procedure success |  | 8 months post-procedure | 
| lesion success rate |  | 0 | 
| resource use |  | 1 year post-procedure | 
| productivity loss |  | 1 year post-procedure | 
| Major Adverse Cardiac Events (MACE) |  | 30 days, and 8 and 12 months. |