This is a randomized study comparing Excimer laser and drug coated balloon Versus Excimer laser and plain balloon versus plain balloon and drug coated balloon to Treat femoropopliteal in-stent restenosis
This is a randomized study comparing Excimer laser and drug coated balloon Versus Excimer laser and plain balloon versus plain balloon and drug coated balloon to Treat femoropopliteal in-stent restenosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Excimer laser and drug coated balloon
Excimer laser and plain balloon
plain balloon and drug coated balloon
Gu Yong Quan
Beijing, Beijing Municipality, China
RECRUITINGPrimary 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
Technical success
Technical success is 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 freedom from clinically-driven target lesion revascularization
Time frame: 12 months
Major Adverse Events
Major adverse events included death, index limb ischemia, index limb amputation, and significant embolic events, which were defined as causing end-organ damage.
Time frame: 12 months
Limb Salvage Rate
Limb Salvage is defined as the freedom from secondary major amputation
Time frame: 12 months
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