YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus

Study Overview
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Brief Summary
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Revascularisation procedures such as percutaneous coronary intervention are associated with overall worse outcomes in patients with diabetes mellitus. Implantation of coronary stents is associated with higher restenosis rates compared to non-diabetic individuals. There is only limited data available on the efficacy and safety of the novel Yukon Choice drug-eluting stent system specifically in patients with diabetes mellitus. The trial will determine the efficacy and safety of the novel Yukon Choice stent system compared to the well established Taxus Liberté stent system. The primary endpoint will be in-stent late lumen loss at 9 months as determined by invasive angiography.

Official Title
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A Prospective, Randomized, Multicenter Comparison of the Drug-Eluting Stent Systems YUKON Choice and TAXUS Liberté in Patients With Diabetes Mellitus

Conditions
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Coronary Arteriosclerosis

Intervention / Treatment
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* Device: Yukon Choice stent system
* Device: Taxus Liberté stent system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years diabetes mellitus symptoms (stable or unstable angina pectoris) or objective evidence of myocardial ischemia one or more de novo lesions in 1, 2 or 3 native coronary arteries clinically significant diameter of stenosis (50-99 % according to visual assessment of operator) lesion must be covered by stent length of no more than 24 mm and stent diameter of no more than 3,5 mm vessel diameter of no more than 4 mm in vessel area adjacent to stenosis informed consent Exclusion Criteria: unprotected left main disease complete occlusion of target vessel in-stent-restenosis stenoses of bypass grafts indication for bypass surgery bifurcation lesions (side branch > 2,0 mm) thrombus in target lesion as visualized by angiography allergy or contraindication to concomitant medication (clopidogrel, aspirin, heparin, contrast media) acute myocardial infarction within preceding 48h participation in another trial pregnancy severe disorder of coagulation or platelet function

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Yukon Choice stent system<br>* coronary stent implantation<br>|
| Active Comparator: 2<br> | Device: Taxus Liberté stent system<br>* coronary stent implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent late lumen loss at follow-up-angiography (9 months) |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary restenosis |  | 9 months | 
| Target vessel revascularisation rate |  | 9 months | 
| Target lesion revascularisation rate |  | 9 months | 
| Late loss (in-segment) |  | 9 months | 
| MLD und diameter of stenosis (%) |  | 9 months | 
| Death |  | 9 months | 
| Success rate index procedure (residual diameter stenosis < 30%) |  | 0 months | 
| Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization) |  | 9 months |