Safety and Efficacy of Peripheral, Cobalt-chromium Sirolimus Eluting Stent (PERS) Versus Cobalt-chromium Stent (Neptune C)

Inclusion criteria

• De novo lesion or restenosis without previously implanted stent, in a common or external iliac artery with a reference diameter of 5 to 12 mm, length up to 10 cm and stenosis ≥ 50% and ≤ 99% (in quantitative assessment by peripheral angiography), which may be treated with one stent or total occlusion of vessels up to 50 mm long.
• Ability to cross the lesion with guidewire (assessed during diagnostic angiography).
• ABI ankle-brachial index <0.9.
• Signs of lower limb ischemia based on the Rutherford scale in the range from 2 to 4.
• Age ≥ 18 years.
• Patient signed informed consent form.

Exclusion criteria

• Life expectancy less than two years.
• Chronic kidney disease in stage III-V.
• Lesion in the previously implanted by-pass.
• Target lesion is a chronic total occlusion of significant length, not eligible for percutaneous revascularization.
• Acute lower limb ischemia.
• Stenosis (> 50%) or occlusion proximally to the lesion being treated.
• Angiographically confirmed thrombus in the lesion to be treated.
• Treatment requires an atherectomy to deliver stent to treated lesion.
• Known allergy or hypersensitivity to clopidogrel.
• Hemorrhagic stroke in the last three months.
• Contraindications for acetylsalicylic acid (hypersensitivity, hemorrhagic diathesis).
• Pregnancy or women of childbearing potential not using effective contraception.
• Active inflammation at the planned access site.