Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia

The aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in patients with critical limb ischemia.

Inclusion Criteria:

• age>18 years
• critical limb ischemia (Rutherford class 4-6)
• angiographic stenosis>50% or occlusion of at least one tibial vessel of at least 40mm for which an interventional treatment is scheduled

Exclusion Criteria:

• need for major amputation known before intervention
• allergy to Paclitaxel
• contraindication for combined antiplatelet treatment
• life expectancy <1 year
• hypersensitivity or contraindication to one of the study drugs
• lack of consent