Skip to main content
OpenTrials
Completed

NCT Number: NCT00368953

YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Arteriosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Leipzig Heart Center

Leipzig, 04289, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yukon Choice stent system

Device

coronary stent implantation

Taxus Liberté stent system

Device

coronary stent implantation

Primary outcomes

  1. "In-stent late lumen loss" at follow-up-angiography (9 months)

    Time frame: 9 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • Translumina GmbH

Registry information

Official study title

A Prospective, Randomized, Multicenter Comparison of the Drug-Eluting Stent Systems YUKON Choice and TAXUS Liberté in Patients With Diabetes Mellitus

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 29, 2006
Registry last updated
Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.