YUKON-drug-eluting Stent Below The Knee - Randomised Double-blind Study

YUKON-drug-eluting Stent Below The Knee - Prospective Randomized Double-blind Multicenter Study

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.

Inclusion Criteria:

• 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 Criteria:

• Coagulation disorder
• Known allergy to contrast medium
• Contraindications to antiplatelet therapy or heparin