BEnefit of Arterial Preparation by LONGitudinal Scoring

BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery

The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery ("scoring") and therefore promote a regular expansion of atheroma by balloon inflation.

Inclusion Criteria:

• Patients ≥ 18-year-old, with symptomatic lower extremity occlusive arterial disease
• Rutherford class of symptom 2 to 5
• Atheromatous ≥ 70 % stenosis or occlusion of SFA and/or PA
• Absence of > 50% residual stenosis of the run-in vessels at the end of procedure
• Presence of at least one patent (no ≥ 50 % stenosis) run-off tibial or fibular vessel to the foot at the end of procedure
• De novo or restenotic lesions, including in-stent restenosis
• Willingness to participate in the study and signature of informed consent

Exclusion Criteria:

• Renal failure with glomerular filtration rate (GFR) 30 ml/min or below, estimated by the Cockroft-Gault equation.
• Women who are pregnant, lactating, or planning to become pregnant during the duration of the study
• Recent artery thrombosis, at risk of distal embolization during percutaneous procedure
• Previous use of a PCB in the lesion during last 15 months
• Extremely calcified lesions, defined by calcification involving ³ 270° of the artery circumference over ³ 15 cm.
• Sub-intimal recanalization
• Tortuous contra-lateral femoral access with difficult cross-over
• Previous or planned surgery of the target lesion
• High risk of bleeding
• Contra-indication to dual antiplatelet therapy for one month, and/or to single antiplatelet therapy for 1 year
• Allergy to aspirin, clopidogrel or heparin
• Life expectancy less than one year