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临床试验/NCT05209672
NCT05209672Unknown不适用

The Relationship Between the Global Limb Anatomic Staging System (GLASS) and Short Term Outcomes of Endovascular Management of Infrainguinal Lesions in Patients With Chronic Limb Threatening Ischemia (CLTI)"

Assiut University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
1
主要终点
Imitate technical failure

研究概览

简要总结

Critical limb threatening ischemia "CLTI 'is not a separate local disease but also it is a part of generalized vascular disorder. A clinical syndrome that can be presented by many symptoms and signs as rest pain, gangrene and chronic ulceration more than 2 weeks (1).

详细描述

The Global Vascular guidelines 'GVG "proposes a new Global Anatomic Staging System (GLASS), GLASS incorporates two novel and important concepts, the target arterial path (TAP) and estimated limb-based patency (LBP). Based on appropriate angiographic imaging, the TAP is defined by the treating surgeon or internationalist as the optimal arterial pathway to restore in-line (pulsatile) flow to the ankle and foot. LBP allows more direct comparison of anatomic outcomes across revascularization strategies in CLTI. The complexity of disease traversed by the TAP is integrated in the GLASS. Femoropopliteal (FP) and infrapopliteal (IP) arterial segments are individually graded on a scale of 0 to 4.(2)(3) Using a consensus based matrix, these segmental grades are combined into three overall GLASS (I-III) stages for the limb, reflecting the complexity of the disease with a proposed likelihood of immediate technical failure ' ITF " and 1 year "LBP " after endovascular intervention of " TAP ' (1)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with infrainguinal CLTI

排除标准

  • Patients with concomitant Aorto-iliac lesions
  • Acute ischemia patients
  • Post Traumatic ischemia

结局指标

主要结局

Imitate technical failure

时间窗: 1 year

Failure of passage of wire or Recoil of vessels during angioplasty

Limb based patency at 1 year

时间窗: 1 year

Patent vessels after endovascular management

次要结局

  • Amputation free survival at 1 year(1 year)
  • Mortality Rate at 1 year(1 year)
  • Amputation rate at 1 year(1 year)

研究者

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

Abdelrahman Ahmed Shawki Roshdi

Responsible investigator

Assiut University

研究点 (1)

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