Coronary Arteriosclerosis
Conditions
Brief summary
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.
Interventions
DEVICEYukon Choice stent system
coronary stent implantation
DEVICETaxus Liberté stent system
coronary stent implantation
Sponsors
Translumina GmbH
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent late lumen loss at follow-up-angiography (9 months) | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Binary restenosis | 9 months |
| Target vessel revascularisation rate | 9 months |
| Target lesion revascularisation rate | 9 months |
| Death | 9 months |
| MLD und diameter of stenosis (%) | 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 |
| Late loss (in-segment) | 9 months |
Countries
Germany
Outcome results
None listed