NCT05670171招募中不适用
Assessment the Safety and Efficacy of Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease: A Multicenter, Randomized, Controlled Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 244
- 试验地点
- 10
- 主要终点
- Clinical-driven revascularization rate of target lesions 12-months after surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%)
排除标准
- •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
结局指标
主要结局
Clinical-driven revascularization rate of target lesions 12-months after surgery
时间窗: 12 months
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.
次要结局
- Primary patency rate in patients with claudication (Rutherford grades 1-3) 12 -months after surgery(12 months)
- Technical success(Intraoperative)
- Rutherford grades at 6 and 12 months postoperatively(6 months and 12 months)
- The rate of unexpected major amputations 12 months after surgery in patients with severe ischemia (Rutherford grades 4-6)(12 months)
- Wagnar grade changes of diabetic foot ulcers at 6 months and 12 months after surgery (Rutherford Grade 4-6)(6 months and 12 months)
- The number of days of hospitalization(1 month)
- The cost of hospitalization(1 month)
- Changes in ankle-brachial index (ABI) at 6 and 12 months after surgery(6 months and 12 months)
研究者
研究点 (10)
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