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 ischemic infrapopliteal arterial disease.
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 compared to treatment with uncoated stent in the below-the-knee arteries consecutively. The purpose of this study is to compare the restenosis rate of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease. Randomisation will be performed by extremity, that may lead to varying treatments within one patient during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
130
Implantation of YUKON Sirolimus-eluting Stent
Implantation of YUKON Stent (uncoated)
Herz-Zentrums Bad Krozingen
Bad Krozingen, Germany
Universitäres Herzzentrum Hamburg
Hamburg, Germany
University Hospital of Tübingen
Tübingen, Germany
Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound)
Time frame: 12 months
Number of reinterventions of target vessel
Time frame: 12 months
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