This is a Prospective randomized controlled study to evaluate the difference of safety,effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions.
Prospective randomized controlled study to evaluate the difference of safety,effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the chocolate balloon group and plain balloon dilatation group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
chocolate balloon dilatation
plain balloon dilatation
Gu Yong Quan
Beijing, Beijing Municipality, China
RECRUITING12-month Primary Patency Rate
systolic velocity ratio \>2.4 as measured by Duplex ultrasound.
Time frame: 12 months
Technical success rate
Technical success was defined as residual stenosis less than 30% by final
Time frame: 1 day
freedom from clinically-driven TLR rate
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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