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YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00368953
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : February 2, 2010
Translumina GmbH
Information provided by:
University of Leipzig

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.

Condition or disease Intervention/treatment Phase
Coronary Arteriosclerosis Device: Yukon Choice stent system Device: Taxus Liberté stent system Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter Comparison of the Drug-Eluting Stent Systems YUKON Choice and TAXUS Liberté in Patients With Diabetes Mellitus
Study Start Date : September 2006
Primary Completion Date : December 2009
Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: 1 Device: Yukon Choice stent system
coronary stent implantation
Active Comparator: 2 Device: Taxus Liberté stent system
coronary stent implantation

Primary Outcome Measures :
  1. "In-stent late lumen loss" at follow-up-angiography (9 months) [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Binary restenosis [ Time Frame: 9 months ]
  2. Target vessel revascularisation rate [ Time Frame: 9 months ]
  3. Target lesion revascularisation rate [ Time Frame: 9 months ]
  4. Late loss (in-segment) [ Time Frame: 9 months ]
  5. MLD und diameter of stenosis (%) [ Time Frame: 9 months ]
  6. Death [ Time Frame: 9 months ]
  7. Success rate index procedure (residual diameter stenosis < 30%) [ Time Frame: 0 months ]
  8. Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization) [ Time Frame: 9 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368953

University of Leipzig Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Translumina GmbH
Principal Investigator: Holger Thiele, MD Heartcenter Leipzig GmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Holger Thiele, University of Leipzig
ClinicalTrials.gov Identifier: NCT00368953     History of Changes
Other Study ID Numbers: Lipsia-Yukon-DM
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases