Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses

• Zilver® Paclitaxel-Eluting Peripheral Stent (Device): Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
• Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating (Device): Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
• Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating (Device): Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Primary outcomes

• The percent diameter stenosis within the study lesion evaluated by conventional angiography. [6 months]: Percent diameter stenosis will be calculated by comparing the minimal lumen diameter to the average of the proximal and distal reference vessel diameters.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* One de novo or restenosed artherosclerotic lesion with ≥ 50% diameter stenosis
* Symptoms of peripheral arterial disease (Rutherford 2-4)

Exclusion Criteria:

* Pregnant, breastfeeding, or planning to become pregnant in the next 5 years
* Less than 18 years old
* Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
* Previous stent in the study vessel

• Thomas Zeller, Prof. Dr. med., Principal investigator, Universitäts Herzzentrum Freiburg - Bad Krozingen