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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
coronary stent implantation
coronary stent implantation
University of Leipzig Heart Center
Leipzig, Germany
"In-stent late lumen loss" at follow-up-angiography (9 months)
Time frame: 9 months
Binary restenosis
Time frame: 9 months
Target vessel revascularisation rate
Time frame: 9 months
Target lesion revascularisation rate
Time frame: 9 months
Late loss (in-segment)
Time frame: 9 months
MLD und diameter of stenosis (%)
Time frame: 9 months
Death
Time frame: 9 months
Success rate index procedure (residual diameter stenosis < 30%)
Time frame: 0 months
Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization)
Time frame: 9 months
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