Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease.
Peripheral Arterial Disease
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Debulking Atherectomy, drug-coated balloon, Stent Angioplasty, Excimer laser atherectomy
Eligibility Criteria
Inclusion Criteria: Age 40-80 years old Rutherford grade 2 to 5 Patients clinically diagnosed with arteriosclerosis obliterans of lower extremity (stenosis of lower extremity arteries greater than 70% or occlusion) and complicated with diabetes The target vessel diameter ≥4mm The total target length of the lesion is 30-210mm The subject is able and willing to comply with all requirements, including 12-month follow-up and evaluation, voluntary participation and informed consen Patients 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 disease Patients with contraindications to antiplatelet, anticoagulant and thrombolytic drugs Patients who are allergic to contrast agents and nickel titanium materials Patients with severe coagulation dysfunction or severe infection that is not under control and should not undergo surgery Severe renal dysfunction (creatinine > 221umol/L) Patients who received local or systemic thrombolytic therapy within 48 hours before surgery Patients who had acute myocardial infarction within 30 days before surgery Patients who had undergone major surgical procedures (heart, abdominal, or peripheral vascular open surgery) within 30 days before surgery Patients who had a stroke within 6 months before surgery Patients whose target arteries had received endovascular surgery within 14 days prior to surgery and patients who had other elective surgery plans during the study period Patients with end-stage renal disease Patients with previous major amputation of the target limb or restenosis after stent or bypass surgery for the target lesion Patients with perforation, dissection, or other vascular injury requiring stenting or surgical operation in the approach or target vessel prior to enrollment Patients with a life expectancy of < 12 months A woman who is pregnant or breastfeeding Patients who are participating in clinical trials of other drugs or devices that do not meet trial endpoints Patients considered unsuitable for this trial by the investigators Exclusion criteria for angiography Patients with severe calcification of the target lesions Patients with aneurysms in the target vessels Patients with acute or subacute thrombus in the target vessel Patients with artificial vessels placed in the limb on the same side of the target vessel
Sites / Locations
- Xuanwu Hospital, Capital Medical UniversityRecruiting
- The Second Hospital of Hebei Medical UniversityRecruiting
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting
- China-Japan Union Hospital, Jilin UniversityRecruiting
- The Affiliated Hospital of Qingdao UniversityRecruiting
- Zhongshan Hospital of Fudan UniversityRecruiting
- Shanghai Pudong Hospital, Fudan UniversityRecruiting
- Shanxi Bethune hospitalRecruiting
- First Affiliated Hospital Xi'an Jiaotong UniversityRecruiting
- Tianjin Medical University General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Debulking Atherectomy
Stent Angioplasty
Excimer laser atherectomy combined with drug-coated balloon angioplasty
Nickel-titanium self-expanding bare stent