YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus

University of Leipzig

Status and phase: Completed; Phase 4

Conditions: Coronary Arteriosclerosis

Treatments: Device: Taxus Liberté stent system; Device: Yukon Choice stent system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00368953

Lipsia-Yukon-DM

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

1

Experimental group

Treatment:

Device: Yukon Choice stent system

2

Active Comparator group

Treatment:

Device: Taxus Liberté stent system