Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
240 participants
INTERVENTIONAL
2006-09-30
2009-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Yukon Choice stent system
coronary stent implantation
2
Taxus Liberté stent system
coronary stent implantation
Interventions
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Yukon Choice stent system
coronary stent implantation
Taxus Liberté stent system
coronary stent implantation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Translumina GmbH
INDUSTRY
University of Leipzig
OTHER
Responsible Party
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University of Leipzig
Principal Investigators
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Holger Thiele, MD
Role: PRINCIPAL_INVESTIGATOR
Heart Center Leipzig - University Hospital
Locations
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University of Leipzig Heart Center
Leipzig, , Germany
Countries
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References
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Stiermaier T, Heinz A, Schloma D, Kleinertz K, Danschel W, Erbs S, Linke A, Boudriot E, Lauer B, Schuler G, Thiele H, Desch S. Five-year clinical follow-up of a randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus (LIPSIA Yukon trial). Catheter Cardiovasc Interv. 2014 Feb 15;83(3):418-24. doi: 10.1002/ccd.25131. Epub 2013 Aug 9.
Desch S, Schloma D, Mobius-Winkler S, Erbs S, Gielen S, Linke A, Yu J, Lauer B, Kleinertz K, Danschel W, Schuler G, Thiele H. Randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus: the LIPSIA Yukon trial. JACC Cardiovasc Interv. 2011 Apr;4(4):452-9. doi: 10.1016/j.jcin.2010.11.016.
Other Identifiers
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Lipsia-Yukon-DM
Identifier Type: -
Identifier Source: org_study_id
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