跳至主要内容
临床试验/NCT07120555
NCT07120555尚未招募不适用

Outcomes of Atherectomy and Balloon Angioplasty Compared to Conventional Angioplasty in Infra-popliteal Chronic Limb-Threatening Ischemia

Assiut University0 个研究点目标入组 60 人开始时间: 2025年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
• Compare the 12-month primary patency rate between the two groups.

研究概览

简要总结

Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of peripheral artery disease (PAD), characterized by rest pain, non-healing ulcers, or gangrene, and is associated with high morbidity and risk of amputation if left untreated. Infra-popliteal arteries are frequently involved in CLTI, especially in diabetic and elderly patients, posing significant challenges due to diffuse, calcified, and long-segment occlusive lesions.

Conventional balloon angioplasty remains a first-line endovascular treatment but is limited by high restenosis and vessel recoil rates. Atherectomy, a plaque debulking technique, aims to improve luminal gain and vessel compliance prior to angioplasty, potentially enhancing outcomes in heavily calcified lesions. The combination of atherectomy and balloon angioplasty has shown promise in reducing dissection rates and improving technical success, yet its superiority over conventional angioplasty alone remains controversial.

Given the growing use of endovascular therapies, a comparative analysis of outcomes between combined atherectomy-balloon angioplasty and conventional angioplasty in infra-popliteal interventions is essential to guide evidence-based management in CLTI patients.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All patients present with CLTI due to isolated infra-popliteal disease with the following criteria:
  • •Denovo or Recoil
  • •Reference tibial vessel diameter at least (2mm)
  • •The diseased tibial artery has a patent distal segment supplying the foot

排除标准

  • •Patients present with:
  • •Previous ipsilateral infrapopliteal bypass surgery
  • •Concomitant iliac or femoral artery lesion
  • •Isolated pedal arch disease
  • •previous atherectomy
  • •Faliure to cross the lesion
  • •Known hypercoagulable disorder or non-atherosclerotic vasculopathy
  • •Severe renal insufficiency (eGFR <30) not on dialysis

研究组 & 干预措施

conventional balloon angioplasty

Experimental

干预措施: Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long (Device)

atherectomy + balloon angioplasty

Experimental

干预措施: atherectomy (Device)

结局指标

主要结局

• Compare the 12-month primary patency rate between the two groups.

时间窗: 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Moustafa Farouk

assistant lecturer

Assiut University

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