This is a Prospective randomized controlled study to evaluate the difference of safety,effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions.
Prospective randomized controlled study to evaluate the difference of safety,effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the Excimer Laser Ablation Combined Drug-coated Balloon group and drug-eluting stent group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments. At the same time, the peri-operative related factors that may affect the end point events, such as preoperative baseline data, lesion characteristics, imaging features, stent fracture, and end point observation indexes were analyzed by regression analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Drug-eluting Stent angioplasty
Excimer Laser Ablation Combined Drug-coated Balloon angioplasty
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
Time frame: 1 day
freedom from clinically-driven TLR
it is defined as the freedom from clinically-driven target lesion revascularization
Time frame: 1 day
Major Adverse Events at 12-month Post Procedure
Major adverse events included death, index limb ischemia, index limb amputation,
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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