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临床试验/NCT04108806
NCT04108806Unknown不适用

Study of Peripheral Arterial Calcification as a Possible Predictor of Outcome After Endovascular Therapy

Assiut University0 个研究点目标入组 100 人开始时间: 2019年9月27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
Major adverse limb events (MALE):

研究概览

简要总结

Aim of the work :

  1. Using different calcification scoring systems to investigate the association between arterial calcification and clinical outcome following endovascular therapy

详细描述

Peripheral arterial disease (PAD) is a worldwide health problem and its prevalence is increasing among aging population. Symptomatic PAD Is a major cause of major amputation with reduction of the functional capacity and quality of life . Arterial calcification is calcium crystallization deposits in the extracellular matrix of the intima and media . Medial calcification is usually associated with chronic kidney disease and diabetes mellitus, while intimal calcification comes usually as a part of atherosclerotic process . The relationship between calcification and PAD is well established . Arterial calcification is associated with increased risk of procedural failure and major amputation . Many calcium scoring systems have been proposed, including peripheral arterial calcium scoring scale (PACSS which highlights the pathologic location of calcification along with the length of the segment affected. The peripheral academic research consortium (PARC) suggested another calcium scoring scale that classified calcification into 4 major grades . The DEFENETIVE Ca++ have proposed another calcium severity scoring . Intravascular Ultrasound (IVUS) is highly sensitive to presence and location of atherosclerotic calcium .

The impact of intimal and medial vascular calcification on the safety and effectiveness of endovascular devices to treat symptomatic peripheral arterial disease (PAD) remains poorly defined warranting continued research to elaborate relationship between calcification and endovascular outcome.

研究设计

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

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with peripheral arterial disease
  • patients with disabling limb claudication
  • patients with rest pain
  • patients with minor tissue loss
  • patients admitted to vascular surgery department for endovascular intervention of a denovo lower limb arterial lesion

排除标准

  • Patient's age less than
  • Patients with major tissue loss [ Rutherford category 6] 3)Patients with recurrent lesion after previous intervention. 4)Patients with double level arterial lesion. 5) Patients refusing to participate in this study

结局指标

主要结局

Major adverse limb events (MALE):

时间窗: 1year

by which we mean repeated endovascular therapy, surgical revision, or major amputation during follow up period.

Primary patency

时间窗: 1 year

which means maintaining vessel patency without restenosis or need for re-intervention.

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

hazem mohamed zaki mohamed

Resident of vascular surgery

Assiut University

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