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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00368953
Other study ID # Lipsia-Yukon-DM
Secondary ID
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


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
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