YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus

Phase 4

Completed

• Conditions: Coronary Arteriosclerosis
• Interventions: Device: Yukon Choice stent system; Device: Taxus Liberté stent system

• Registration Number: NCT00368953
• Lead Sponsor: University of Leipzig

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-28
• Study First Submitted QC: 2006-08-28
• Study First Posted: 2006-08-29
• Study Start: 2006-09
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-02-01
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Yukon Choice stent system	-
2	Taxus Liberté stent system	-

Primary Outcome Measures

Name	Time	Method
"In-stent late lumen loss" at follow-up-angiography (9 months)	9 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Leipzig Heart Center; 🇩🇪 Leipzig, Germany