YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Translumina GmbH
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00368953
First received: August 28, 2006
Last updated: February 1, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Coronary Arteriosclerosis
Device: Yukon Choice stent system
Device: Taxus Liberté stent system
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • "In-stent late lumen loss" at follow-up-angiography (9 months) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Binary restenosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target vessel revascularisation rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target lesion revascularisation rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Late loss (in-segment) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • MLD und diameter of stenosis (%) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Success rate index procedure (residual diameter stenosis < 30%) [ Time Frame: 0 months ] [ Designated as safety issue: No ]
  • Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Yukon Choice stent system
coronary stent implantation
Active Comparator: 2 Device: Taxus Liberté stent system
coronary stent implantation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368953

Locations
Germany
University of Leipzig Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Translumina GmbH
Investigators
Principal Investigator: Holger Thiele, MD University of Leipzig
  More Information

No publications provided by University of Leipzig

Additional 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
Study First Received: August 28, 2006
Last Updated: February 1, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 17, 2014