This study is intended to evaluate the long-term effectiveness of treatment of de novo or restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™ Vascular Stent which has received the CE mark for commercial use. The study is designed as a single arm non-randomized post-approval study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Stenting of the Above-the-Knee Femoropopliteal Artery
Herz-Zentrum
Bad Krozingen, Germany
Gemeinschaftspraxis
Leipzig, Germany
Universitatsklinikum Magdeburg
Magdeburg, Germany
Primary patency of the treated lesion within the superficial femoral artery
Time frame: 1 year after patient enrollment
Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement
Time frame: 1 year after patient enrollment
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