Back to resultsYUKON Choice Versus TAXUS Liberté in Diabetes Mellitus
Primary Purpose
Coronary Arteriosclerosis
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Yukon Choice stent system
Taxus Liberté stent system
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Arteriosclerosis
Eligibility 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
Sites / Locations
- University of Leipzig Heart Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
"In-stent late lumen loss" at follow-up-angiography (9 months)
Secondary Outcome Measures
Binary restenosis
Target vessel revascularisation rate
Target lesion revascularisation rate
Late loss (in-segment)
MLD und diameter of stenosis (%)
Death
Success rate index procedure (residual diameter stenosis < 30%)
Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization)
Full Information
NCT ID
NCT00368953
First Posted
August 28, 2006
Last Updated
February 1, 2010
Sponsor
University of Leipzig
Collaborators
Translumina GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00368953
Brief Title
YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus
Official Title
A Prospective, Randomized, Multicenter Comparison of the Drug-Eluting Stent Systems YUKON Choice and TAXUS Liberté in Patients With Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Leipzig
Collaborators
Translumina GmbH
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Yukon Choice stent system
Intervention Description
coronary stent implantation
Intervention Type
Device
Intervention Name(s)
Taxus Liberté stent system
Intervention Description
coronary stent implantation
Primary Outcome Measure Information:
Title
"In-stent late lumen loss" at follow-up-angiography (9 months)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Binary restenosis
Time Frame
9 months
Title
Target vessel revascularisation rate
Time Frame
9 months
Title
Target lesion revascularisation rate
Time Frame
9 months
Title
Late loss (in-segment)
Time Frame
9 months
Title
MLD und diameter of stenosis (%)
Time Frame
9 months
Title
Death
Time Frame
9 months
Title
Success rate index procedure (residual diameter stenosis < 30%)
Time Frame
0 months
Title
Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization)
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, MD
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leipzig Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23873579
Citation
Stiermaier T, Heinz A, Schloma D, Kleinertz K, Danschel W, Erbs S, Linke A, Boudriot E, Lauer B, Schuler G, Thiele H, Desch S. Five-year clinical follow-up of a randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus (LIPSIA Yukon trial). Catheter Cardiovasc Interv. 2014 Feb 15;83(3):418-24. doi: 10.1002/ccd.25131. Epub 2013 Aug 9.
Results Reference
derived
PubMed Identifier
21511226
Citation
Desch S, Schloma D, Mobius-Winkler S, Erbs S, Gielen S, Linke A, Yu J, Lauer B, Kleinertz K, Danschel W, Schuler G, Thiele H. Randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus: the LIPSIA Yukon trial. JACC Cardiovasc Interv. 2011 Apr;4(4):452-9. doi: 10.1016/j.jcin.2010.11.016.
Results Reference
derived
Learn more about this trial
YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus
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