Clinical trial NCT00368953: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Arteriosclerosis
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Translumina GmbH
First posted: 2006-08-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: "In-stent late lumen loss" at follow-up-angiography (9 months)
timeFrame: 9 months
Secondary outcomes:
measure: Binary restenosis
timeFrame: 9 months
measure: Target vessel revascularisation rate
timeFrame: 9 months
measure: Target lesion revascularisation rate
timeFrame: 9 months
measure: Late loss (in-segment)
timeFrame: 9 months
measure: MLD und diameter of stenosis (%)
timeFrame: 9 months
measure: Death
timeFrame: 9 months
measure: Success rate index procedure (residual diameter stenosis < 30%)
timeFrame: 0 months
measure: Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization)
timeFrame: 9 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig Heart Center
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Holger Thiele, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.