Status:
COMPLETED
YUKON-drug-eluting Stent Below The Knee - Randomised Double-blind Study
Lead Sponsor:
Herz-Zentrums Bad Krozingen
Conditions:
Arterial Occlusive Diseases
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the effectiveness of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with i...
Detailed Description
Based on the fact that drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries, we assume that YUKON-BTX-Sirolimus-eluting stent has a superior restenosis rate comp...
Eligibility Criteria
Inclusion
- Clinical diagnosis of peripheral arterial occlusive disease as defined by Rutherford 2-5
- De-novo stenosis of \> 70% diameter stenosis in the tibioperoneal trunc, anterior and/or posterior tibial and/or peroneal artery
- Target lesion length of ≤ 45 mm
Exclusion
- Coagulation disorder
- Known allergy to contrast medium
- Contraindications to antiplatelet therapy or heparin
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00664963
Start Date
April 1 2006
End Date
April 1 2010
Last Update
December 17 2014
Active Locations (3)
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1
Herz-Zentrums Bad Krozingen
Bad Krozingen, Germany, 79189
2
Universitäres Herzzentrum Hamburg
Hamburg, Germany, 22527
3
University Hospital of Tübingen
Tübingen, Germany, 72076