Single Versus Multiple Vessels Endovascular Tibial Arteries Revascularization for Critical Limb Ischemia
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
- 否
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
Who undergo single tibial artery Endovascular Revascularization
干预措施: Endovascular Revascularization (Procedure)
Multiple tibialis vessels Endovascular Revascularization
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
Mohammed Zakria Mohammed El Amir
Vascular surgery resident
Aswan University
