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临床试验/NCT06127134
NCT06127134进行中(未招募)不适用

Outcomes of Straight-line Flow Versus Angiosome-targeted Angioplasty in Treatment of Critical Lower Limb Ischemia

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Technical success

研究概览

简要总结

Peripheral arterial disease (PAD) affects more than 200 million people worldwide. Although over 50% are asymptomatic, it accounts for 4% of all amputations.

The ischemic limb must be revascularized to help wound healing, reduce the pain of ischemia and preserve the limb's function. So, surgical and percutaneous revascularization choices must be considered in CLI. Classically, CLI revascularization aims to provide at least one patent vessel that delivers in-line flow to the foot.

Today, the investigators live in a new era of angioplasty evolving and substituting open vascular surgery, so expanding research on endovascular strategy has been noticed.This confirms the profound impact of angioplasty in vascular surgery as one of the fastest-growing branches of medicine

Infrapopliteal artery occlusive disease (IPOD) is a significant cause of critical limb-threatening ischemia (CLTI). The worldwide prevalence of IPOD is between 4.5% and 29%, and most patients live in low-income countries.

The angiosomal concept was derived from plastic surgery for the skin flap. This concept delineates the human body into three-dimensional blocks of tissue from the skin to bone and also provides practical application of vascular anatomy for reconstructive surgery. An angiosome is an anatomic unit of tissue consisting of skin, subcutaneous, muscle, and bone fed by a source artery and drained by a specific vein.

According to the angiosomal concept, the foot is divided into six distinct angiosomes fed by source arteries, three from the posterior tibial, two from the peroneal, and one from the anterior tibial artery, with functional artery-to-artery connections among muscle, fascia, and skin. Numerous direct inter-arterial connections occur between the foot's main arteries, which provide alternative pathways of blood flow when disruption or compromise affects the arteries that directly feed the angiosome.

On the other hand, in patients with CLI, where only one vessel runoff can be established to the foot, direct flow into a patent pedal arch is essential to improve their clinical outcomes.

Conventional Endovascular therapy aims to the re-establishment of pulsatile straight-line flow to the lower limb. This results in relieving ischemic pain, healing ulcers, achieving limb salvage, improving quality of life, and potentially prolonging survival.

So it became essential to know the differential impact of both concepts on CLI revascularization.

详细描述

Introduction

Peripheral arterial disease (PAD) affects more than 200 million people worldwide. Although over 50% are asymptomatic, it accounts for 4% of all amputations.

The ischemic limb must be revascularized to help wound healing, reduce the pain of ischemia and preserve the limb's function. So, surgical and percutaneous revascularization choices must be considered in CLI. Classically, CLI revascularization aims to provide at least one patent vessel that delivers in-line flow to the foot.

Today, the investigators live in a new era of angioplasty evolving and substituting open vascular surgery, so expanding research on endovascular strategy has been noticed.This confirms the profound impact of angioplasty in vascular surgery as one of the fastest-growing branches of medicine

Infrapopliteal artery occlusive disease (IPOD) is a significant cause of critical limb-threatening ischemia (CLTI). The worldwide prevalence of IPOD is between 4.5% and 29%, and most patients live in low-income countries.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient with documented symptomatic infragenicular chronic arterial disease with or without supra-genicular lesion
  • Diabetic or not
  • Rutherford grades 4, 5 and 6
  • The patient is able and willing to comply with study follow-up requirements.

排除标准

  • Contraindication for angioplasty
  • unsuitable for angioplasty revascularization strategy
  • claudication case
  • tissue loss is considered to be primarily of venous etiology.
  • Patient with full-thickness gangrene of the foot.
  • Widespread infection of the lower limb needing amputation

结局指标

主要结局

Technical success

时间窗: first 24 hours

good distal flow and arterial pulsation which are documented by angiography pre \& post procedure with residual stenosis \<30%

Clinical success

时间窗: first 6 month

limb salvage and wound status improves at least one class in Rutherford classification in patients with critical limb ischemia.

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

Ahmed Mohamed Elsaid Hassan Bedeer

Principal Investigator

Kafrelsheikh University

研究点 (1)

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