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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy
Late Lumen Loss (LLL) in the target lesion documented by angiography
Late Lumen Loss (LLL) in the target lesion documented by angiography
Time frame: 6 months
Number of events of angiographic occlusive restenosis
number of events of angiographic occlusive restenosis
Time frame: 6 months
Number of events of target lesion revascularization (TLR)
number of events of target lesion revascularization
Time frame: 12 months
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