跳至主要内容
临床试验/NCT04622878
NCT04622878Unknown不适用

Combined Treatment ( Image Guided Thrombectomy and Endovascular Therapy With Open Femoral Access ) for Acute Limb Ischemia

Assiut University0 个研究点目标入组 100 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
limb salvage

研究概览

简要总结

Acute limb ischemia (ALI) is a sudden decrease in limb perfusion due to either an embolic or a thrombotic vascular occlusion, defined as the presence of symptoms within two weeks of onset. The profound ischemia represents an emergency in which delayed treatment results in limb loss and, potentially, death. Therefore, timely diagnosis and proper treatments for ALI are important.

Both surgical thrombectomy and endovascular treatment have benefits and drawbacks. Surgical thrombectomy using Fogarty embolectomy catheter has been the standard therapy because it is rapid and effective in cases of embolic ALI. However, blind surgical thrombectomy can result in poor revascularization or unexpected vascular injury in the presence of underlying arterial atherosclerosis or in the presence of subacute and chronic thrombi. In addition, thrombosis of runoff vessels is difficult to remove.

Endovascular management using catheter-directed thrombolysis (CDT) has emerged as an alternative to surgery. It is less invasive, and does not directly damage the vascular endothelium with the capacity to clear thrombus in the small vessels. However, long treatment duration may worsen the clinical situation. Besides, a thrombus of more than two weeks does not respond well to the thrombolysis, and it is difficult to determine the exact stage of thrombus according to the clinical history. These problems may be minimized by combined treatment, which includes surgical thrombectomy and endovascular treatment.

详细描述

The aim of our research is to evaluate the effectiveness and safety of combined treatment (surgical thrombectomy and endovascular treatment) for ALI with various clinical considerations

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with acute onset of lower limb pain with various degrees of movement compromise.
  • History of intermittent claudication with a sudden worsening of claudication and pain at rest for less than one month.
  • Patients with Duplex or MSCT angiography of the lower limbs showing embolic events on healthy vessels or thrombosis of diseased vessels with or without collateralization.
  • Thrombus in a poor location that is difficult to be removed by surgical thrombectomy alone.
  • Acute lower limb ischemia due to acute arterial graft occlusion

排除标准

  • - Medically compromised patients, not fit for the intervention.
  • Patients with critical chronic limb ischemia (grade III, IV).
  • Patients with known vasculitis or lab investigations suggesting vasculitis before treating the cause.
  • Patients who refused the intervention.

结局指标

主要结局

limb salvage

时间窗: immediately post operative

Technical success rates is defined as patency of the treated vessel segment with less than 20 % residual stenosis , without dissection and restoration of in line flow to foot , weight and height of the pt will be combined to report BMI kg/m\^2

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

Kerolos Raafat Khalil Gad

Resident physician at vascular surgery department ، Assiut University

Assiut University

相似试验