YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus

February 1, 2010 updated by: University of Leipzig

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • University of Leipzig Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Device: Taxus Liberté stent system
coronary stent implantation
EXPERIMENTAL: 1
Device: Yukon Choice stent system
coronary stent implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
"In-stent late lumen loss" at follow-up-angiography (9 months)
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 9 months
9 months
Binary restenosis
Time Frame: 9 months
9 months
Target vessel revascularisation rate
Time Frame: 9 months
9 months
Target lesion revascularisation rate
Time Frame: 9 months
9 months
Late loss (in-segment)
Time Frame: 9 months
9 months
MLD und diameter of stenosis (%)
Time Frame: 9 months
9 months
Success rate index procedure (residual diameter stenosis < 30%)
Time Frame: 0 months
0 months
Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization)
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

Translumina GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

August 28, 2006

First Submitted That Met QC Criteria

August 28, 2006

First Posted (ESTIMATE)

August 29, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2010

Last Update Submitted That Met QC Criteria

February 1, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lipsia-Yukon-DM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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