Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease.

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.

Inclusion Criteria:Age 40-80 years oldRutherford grade 2 to 5Patients clinically diagnosed with arteriosclerosis obliterans of lower extremity (stenosis of lower extremity arteries greater than 70% or occlusion) and complicated with diabetesThe target vessel diameter ≥4mmThe total target length of the lesion is 30-210mmThe subject is able and willing to comply with all requirements, including 12-month follow-up and evaluation, voluntary participation and informed consenPatients with ipsilateral iliac artery inflow tract patency (stenosis ≤50%) or ipsilateral iliac artery inflow tract lesions and successful management (residual stenosis < 30% after treatment, no severe (≥ grade D) flow-limiting dissection , no thrombosis, embolism or other serious adverse events)Patients with at least one infrapopliteal artery for patency of the affected lateral foot before or after intraoperative treatment (stenosis ≤50%)Exclusion Criteria:Patients with vasculitis or Berger diseasePatients with contraindications to antiplatelet, anticoagulant and thrombolytic drugsPatients who are allergic to contrast agents and nickel titanium materialsPatients with severe coagulation dysfunction or severe infection that is not under control and should not undergo surgerySevere renal dysfunction (creatinine > 221umol/L)Patients who received local or systemic thrombolytic therapy within 48 hours before surgeryPatients who had acute myocardial infarction within 30 days before surgeryPatients who had undergone major surgical procedures (heart, abdominal, or peripheral vascular open surgery) within 30 days before surgeryPatients who had a stroke within 6 months before surgeryPatients whose target arteries had received endovascular surgery within 14 days prior to surgery and patients who had other elective surgery plans during the study periodPatients with end-stage renal diseasePatients with previous major amputation of the target limb or restenosis after stent or bypass surgery for the target lesionPatients with perforation, dissection, or other vascular injury requiring stenting or surgical operation in the approach or target vessel prior to enrollmentPatients with a life expectancy of < 12 monthsA woman who is pregnant or breastfeedingPatients who are participating in clinical trials of other drugs or devices that do not meet trial endpointsPatients considered unsuitable for this trial by the investigators Exclusion criteria for angiographyPatients with severe calcification of the target lesionsPatients with aneurysms in the target vesselsPatients with acute or subacute thrombus in the target vesselPatients with artificial vessels placed in the limb on the same side of the target vessel