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临床试验/NCT07427108
NCT07427108招募中不适用

Road Mapping Guided Puncture Versus Ultrasound Guided Puncture During Retrograde Angioplasty Feasibility and Safety

Sohag University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
1
主要终点
Success rate

研究概览

简要总结

The study aims to compare the technical feasibility and safety of road mapping-guided versus ultrasound-guided retrograde arterial puncture in patients with (CLTI) as measured by:

  • Puncture success rate
  • Access-related complication rate (e.g., hematoma, vessel dissection, perforation)

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

入选标准

  • Adults : Both male and female participants.
  • Diagnosed with critical limp threatening ischemia (CLTI):
  • significant occlusions in the femoropopliteal
  • o Rutherford Class 5: Non-healing wounds or ulcers
  • Failed or unable to achieve antegrade access:
  • Patients requiring retrograde puncture for the procedure.
  • Planned intervention with retrograde access: Candidates for endovascular interventions, including angioplasty, stent deployment

排除标准

  • Active infection at the puncture site: Any localized infection, particularly over the ankle region , will be an exclusion.
  • Severe calcification or anatomical abnormalities: Patients with excessive arterial calcification or significant anatomical distortion preventing safe retrograde puncture.

研究组 & 干预措施

Road Mapping Guided Puncture

Experimental

干预措施: Road-map guided versus US guided retrograde access (Procedure)

Ultrasound Guided Puncture

Active Comparator

干预措施: Road-map guided versus US guided retrograde access (Procedure)

结局指标

主要结局

Success rate

时间窗: 12 months

Complication rate

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

Yohana Farouz Fayez

Vascular surgery resident, Sohag University Hospitals, Egypt

Sohag University

研究点 (1)

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