This is a randomized study comparing stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
This is a randomized study comparing balloon angioplasty adjunctive stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
221
Gu Yong Quan
Beijing, Beijing Municipality, China
12-month Primary Patency Rate
systolic velocity ratio \>2.4 as measured by Duplex ultrasound.
Time frame: 12 months
Technical success
Technical success was defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection.
Time frame: 1 day
freedom from clinically-driven TLR
it is defined as thefreedom from clinically-driven target lesion revascularization
Time frame: 12 months
Major Adverse Events at 12-month Post Procedure
Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization , and significant embolic events, which were defined as causing end-organ damage.
Time frame: 12 months
12-month Limb Salvage Rate
Limb Salvage is defined as the freedom from secondary major amputation
Time frame: 12 months
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