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临床试验/NCT07383064
NCT07383064已完成不适用

Single Versus Multiple Vessels Endovascular Tibial Arteries Revascularization for Critical Limb Ischemia

Aswan University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Salvageable of limb(( patients don't need for major amputation )) sabe limb from major amputation

研究概览

简要总结

This study aims to Compare the outcomes of angioplasty for single tibial vessel occlusion versus multiple tibial vessel occlusions in patients with critical limb ischemia. Assess the effectiveness and safety of angioplasty in treating different extents of tibial vessel occlusions. Evaluate the impact of angioplasty on limb salvage rates, healing of ischemic wounds, and overall clinical improvement in patients with CLI.

详细描述

This study demonstrates that in patients with chronic limb-threatening ischemia (CLTI), revascularization resulting in the patency of multiple tibial vessels is associated with significantly superior clinical outcomes compared to single-vessel patency. While both strategies were equally safe and technically feasible, the multiple-tibial-vessel (MTV) group achieved perfect limb salvage, higher primary patency, lower restenosis rates, and significantly better wound healing at six months. These findings underscore the importance of robust tibial runoff, supporting the "angiogenic reserve" concept where multiple patent vessels provide redundant perfusion pathways that enhance the durability of revascularization and promote tissue repair. Consequently, when anatomically feasible, treatment strategies should prioritize the establishment or preservation of multi-vessel tibial outflow to optimize limb salvage and functional recovery in this high-risk population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Patients with:
  • Rutherford Class 5 and 6 Single or multiple occlusive infrapopliteal vessel lesions In-flow vessel (superficial femoral artery and popliteal artery) free from flow-limiting lesion or in-flow lesion correction with bypass or endovascular intervention during index procedure.

排除标准

  • Patients with:
  • Prior vascular intervention in target limb Technical/hemodynamic failure inflow occlusive disease. Patient with allergy to the contrast

研究组 & 干预措施

Single tibial artery Endovascular Revascularization

Active Comparator

Who undergo single tibial artery Endovascular Revascularization

干预措施: Endovascular Revascularization (Procedure)

Multiple tibialis vessels Endovascular Revascularization

Sham Comparator

Who undergo more than one tibial artery Revascularization

干预措施: Endovascular Revascularization (Procedure)

结局指标

主要结局

Salvageable of limb(( patients don't need for major amputation )) sabe limb from major amputation

时间窗: 2years

Salvageable of limb

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

Mohammed Zakria Mohammed El Amir

Vascular surgery resident

Aswan University

研究点 (1)

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