This study was designed to compare excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.
This is a randomized study comparing excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia.
Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia.
Yongquan Gu
Beijing, Beijing Municipality, China
RECRUITINGTarget lesion revascularization rate
Free target vascular occlusion and clinically driven target lesion revascularization rate confirmed by ultrasound examination.
Time frame: 6-months
Incidence of major adverse events
Incidence of major adverse events (including operative-related arterial dissection, perforation, rupture, embolization, acute thrombosis, pseudoaneurysm, and hematoma formation).
Time frame: 6-months
Major amputation rate
The rate of major amputation.
Time frame: 6-months
Mortality
The ratio of deaths
Time frame: 6-months
Ankle Brachial Index
Time frame: 6-months
transcutaneous oxygen pressure
Time frame: 6-months
Wound healing wagner score (for patients with Rutherford classification 5)
Wound healing wagner score (for patients with Rutherford classification 5).
Time frame: 6-months
Length of hospital stay
Time frame: 6-months
hospitalization costs
Time frame: 6-months
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