Status:
COMPLETED
YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus
Lead Sponsor:
University of Leipzig
Collaborating Sponsors:
Translumina GmbH
Conditions:
Coronary Arteriosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00368953
Start Date
September 1 2006
End Date
December 1 2009
Last Update
February 2 2010
Active Locations (1)
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1
University of Leipzig Heart Center
Leipzig, Germany, 04289