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