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

University of Leipzig1 site in 1 country240 target enrollmentSeptember 2006

ConditionsCoronary Arteriosclerosis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Coronary Arteriosclerosis
Sponsor: University of Leipzig
Enrollment: 240
Locations: 1
Primary Endpoint: "In-stent late lumen loss" at follow-up-angiography (9 months)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

December 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Leipzig

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

Outcomes

Primary Outcomes

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

Time Frame: 9 months

Secondary Outcomes

Binary restenosis(9 months)
Target vessel revascularisation rate(9 months)
Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization)(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)