Drug Eluting Balloon in peripherAl inTErvention SFA

Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study

The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.

Inclusion Criteria:

• age>18 years
• intermittent claudication(Fontane III or IV)
• angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm
• at least one below-knee vessel to the ankle

Exclusion Criteria:

• allergy to Paclitaxel
• contraindication for combined antiplatelet treatment
• life expectancy <1 year
• hypersensitivity or contraindication to one of the study drugs
• lack of consent