YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus

Coronary Arteriosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368953
• Other study ID #: Lipsia-Yukon-DM
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2006
• Last updated: February 1, 2010
• Start date: September 2006
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Device:
• Yukon Choice stent system
coronary stent implantation
• Taxus Liberté stent system
coronary stent implantation

Locations

Country	Name	City	State
Germany	University of Leipzig Heart Center	Leipzig

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	Translumina GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"In-stent late lumen loss" at follow-up-angiography (9 months)		9 months	No
Secondary	Binary restenosis		9 months	No
Secondary	Target vessel revascularisation rate		9 months	No
Secondary	Target lesion revascularisation rate		9 months	No
Secondary	Late loss (in-segment)		9 months	No
Secondary	MLD und diameter of stenosis (%)		9 months	No
Secondary	Death		9 months	Yes
Secondary	Success rate index procedure (residual diameter stenosis < 30%)		0 months	No
Secondary	Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization)		9 months	Yes