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临床试验/NCT00876668
NCT00876668Unknown不适用

Pilot-Study to Evaluate the Clinical Significance of the Fluorescence Videoangiography With Indocyanine-Green in Patients With PAD, Rutherford Classification II-V, and Relation to Common Diagnostics.

Johann Wolfgang Goethe University Hospital0 个研究点目标入组 25 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25
主要终点
Diagnostic Quality of the fluorescence -videoangiography at patients with PAD

研究概览

简要总结

The aim of the study is to compare the diagnostic value of this non-invasive vascular imaging tool with the established vascular diagnostic methods for PAD in order to get prognostic data.

A higher sensitivity of Fluorescence angiography in order to recognize progression of critical limb ischemia could lead to earlier therapeutic interventions and thereby increase limb salvage. A diagnostic gap would be closed.

详细描述

Critical limb ischemia (CLI) occurs when the peripheral microcirculation is impaired by arterial stenoses or occlusions. In opposite to earlier studies that only evaluated intermittent claudication due to peripheral arterial disease (PAD), rest pain and trophic changes in the affected extremity are due to reduced microcirculation. Though the main reason for CLI is the existing PAD, many processes responsible for pain and other pad-associated symptoms are triggered by a reduced microcirculation so that attempts to enhance the dermal perfusion by pharmacological or other manipulations may ameliorate the results of vascular treatment. These attempts may be the best options for patients, in which vascular surgery was not successful or primarily impossible.

A Laser-induced fluorescence videoangiography is currently being used in ophthalmology to display the vessels of the eye background. Due to technical improvements, it has become a standard procedure. This trial aims at establishing laser-induced fluorescence videoangiography as standard procedure in vascular surgery. This would be of benefit for the patient as the technique does not require the use of ionising radiation and is possible for patients suffering to renal failure.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Patient > 18 years
  • Chronical ischemia of extremities, Rutherford categories 4, 5 and 6 with indication for vascular reconstruction
  • Acute danger of extremity loss due tue ischemia with indication for vascular surgery

排除标准

  • Patient < 18 years
  • Informed consent not signed
  • Patient has a MRSA infection
  • Patient has an iodine allergy
  • Pregnant female Patient
  • Known anaphylactic reactions after injections of contrast media or indocyanine green

结局指标

主要结局

Diagnostic Quality of the fluorescence -videoangiography at patients with PAD

时间窗: one year

次要结局

  • Correlation of the results of fluorescence videoangiography, ankle-brachial-index, i.a. DSA, clinical examination(one year)

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other

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