This is a randomized study comparing stent and plaque excision systems in treatment of Iliac artery occlusive disease.
This is a randomized study comparing stent and plaque excision systems in treatment of Iliac artery occlusive disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
stent
plaque excision system
Yongquan Gu
Beijing, Beijing Municipality, China
RECRUITING12-month Primary Patency Rate
Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis \>50% with a peak systolic velocity ratio \>2.4 as measured by Duplex ultrasound.
Time frame: 12 months
12-month Limb Salvage Rate
Limb Salvage is defined as the freedom from secondary major amputation
Time frame: 12 months
Index Limb Ischemia at 6-month Follow up
Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.
Time frame: 6 months
Index Limb Ischemia at 12-month Follow up
Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.
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
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