Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
49
Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
Freedom from TLR (Target Lesion Revascularization)
Fraction of study subjects without need for retreatment at treatment location
Time frame: 6 months
Freedom from TLR (Target Lesion Revascularization)
Fraction of study subjects without need for retreatment at treatment location
Time frame: 12 months
Freedom from TLR (Target Lesion Revascularization)
Fraction of study subjects without need for retreatment at treatment location
Time frame: 24 months
Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
Functioning revascularization without adjunctive measures
Time frame: 12months
Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
Functioning revascularization without adjunctive measures
Time frame: 24 months
Event Free Survival
Alive without vascular events
Time frame: 24 months
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