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YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus

NCT00368953 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2010-02-02

No results posted yet for this study

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.

Conditions

  • Coronary Arteriosclerosis

Interventions

DEVICE

Yukon Choice stent system

coronary stent implantation

DEVICE

Taxus Liberté stent system

coronary stent implantation

Sponsors & Collaborators

  • Translumina GmbH

    collaborator INDUSTRY

  • University of Leipzig

    lead OTHER

Principal Investigators

  • Holger Thiele, MD · Heart Center Leipzig - University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00368953 on ClinicalTrials.gov