PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents

Balloon Angioplasty vs. Primary Stenting of Femoropopliteal Arteries Using Self-Expandable Nitinol Stents - a Randomized Controlled Trial

The investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.

Inclusion Criteria:

• symptomatic peripheral artery disease with severe intermittent claudication (Fontaine stage IIb)
• critical limb ischemia in patients with stenosis or occlusions originating in the SFA
• up to 25 cm length of stenosis/occlusion

Exclusion Criteria:

• previous bypass surgery at the site of treatment
• history of intolerance of anti-platelet therapy
• adverse reaction to heparin
• bleeding diathesis
• creatinine >2.5 mg/dL
• active bacterial infection
• allergy to contrast media
• previous stent placement at or immediately adjacent to the target lesion