研究单位：[1]Xuan Wu Hospital of Capital Medical University,Beijing,Beijing,China,100053[2]The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School[3]The Second Hospital of Hebei Medical University[4]Shanxi Bethune Hospital[5]First Affiliated Hospital Xi'an Jiaotong University[6]The Affiliated Hospital of Qingdao University[7]Shanghai Pudong Hospital[8]Tianjin Medical University General Hospital[9]China-Japan Union Hospital, Jilin University[10]Fudan University[11]The Second Hospital of Hebei Medical University,Shijia Zhuang,Hebei,China,050000[12]The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School,Nanjing,Jiangsu,China,210008[13]China-Japan Union Hospital, Jilin University,Changchun,Jilin,China,130033[14]The Affiliated Hospital of Qingdao University,Qingdao,Shandong,China,266003[15]Zhongshan Hospital of Fudan University,Shanghai,Shanghai,China,200032[16]Shanghai Pudong Hospital, Fudan University,Shanghai,Shanghai,China,201399[17]Shanxi Bethune hospital,Taiyuan,Shanxi,China,030032[18]First Affiliated Hospital Xi'an Jiaotong University,Xi'an,Shanxi,China,710061[19]Tianjin Medical University General Hospital,Tianjin,Tianjin,China,300052
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.
