DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia

Randomized Trial Comparing Drug Coated Balloon vs Plain Balloon Angioplasty in Critical Limb Ischemia and Treatment of Long Lesions in Crural Arteries

The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study

Results will be defined as:

Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years.

Primary endpoints:

Primary Patency at 12 months, TLR (clinical driven),

Secondary endpoints:

Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,

Inclusion Criteria:

• Critical limb ischemia. Rutherford class 4-6
• Crural disease, long lesions, more than 2 cm.
• Life expectancy > 1year
• > 18 years

Exclusion Criteria:

• Pregnancy
• Patients disapproval
• Allergy to drug or contrast