In order to assessment the safety and efficacy of debulking atherectomy versus stent angioplasty for limb ischaemia of diabetic lower limb atherosclerosis-occlusive disease, we intend to conduct a prospective, multicenter, randomized controlled, non-inferiority trial. The main surgical methods included stent angioplasty group (Nickel-titanium self-expanding bare stent) and debulking atherectomy group (Excimer laser atherectomy combined with drug-coated balloon angioplasty). The sample size was 244 patients, and the patients were followed up at 30 days, 180 days, and 365 days after operation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
Excimer laser atherectomy combined with drug-coated balloon angioplasty
Nickel-titanium self-expanding bare stent
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGThe Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
RECRUITINGChina-Japan Union Hospital, Jilin University
Changchun, Jilin, China
RECRUITINGThe Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
RECRUITINGZhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Pudong Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGShanxi Bethune hospital
Taiyuan, Shanxi, China
RECRUITINGFirst Affiliated Hospital Xi'an Jiaotong University
Xi’an, Shanxi, China
RECRUITINGTianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGClinical-driven revascularization rate of target lesions 12-months after surgery
Clinically driven revascularization of target lesions was defined as a reduction of ABI ≥20% or \>0.15 due to clinical symptoms or compared to the ABI after the initial surgery, any re-interventional therapy required for the target lesion.
Time frame: 12 months
Technical success
Intraoperative angiography will demonstrated residual stenosis of the treated vessel \<30%
Time frame: Intraoperative
Primary patency rate in patients with claudication (Rutherford grades 1-3) 12 -months after surgery
Primary patency was defined as peak systolic velocity ratio (PSVR) ≤2.4 (stenosis ≤50%) at 12-month follow-up.
Time frame: 12 months
The rate of unexpected major amputations 12 months after surgery in patients with severe ischemia (Rutherford grades 4-6)
The rate of unexpected major amputations 12 months after surgery in patients with severe ischemia (Rutherford grades 4-6)
Time frame: 12 months
Wagnar grade changes of diabetic foot ulcers at 6 months and 12 months after surgery (Rutherford Grade 4-6)
Wagnar grade changes diabetic foot ulcers at 6 months and 12 months after surgery (Rutherford Grade 4-6)
Time frame: 6 months and 12 months
Rutherford grades at 6 and 12 months postoperatively
Rutherford grades at 6 and 12 months postoperatively
Time frame: 6 months and 12 months
Changes in ankle-brachial index (ABI) at 6 and 12 months after surgery
Changes in ankle-brachial index (ABI) at 6 and 12 months after surgery
Time frame: 6 months and 12 months
The number of days of hospitalization
The number of days of hospitalization
Time frame: 1 month
The cost of hospitalization
The cost of hospitalization
Time frame: 1 month
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