Trans-pedal Access for Endovascular Revascularization in Complex Infra-popliteal Lesions in Critically Ischemic Limb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- amputation free survival rates
研究概览
简要总结
Background: critical limb ischemia is one of the most challenging cases we face nowadays with high risk for amputation, retrograde trans-pedal angioplasty offers an alternative technique after failure of traditional ante-grade angioplasty.
Patients and Methods: 96 patients underwent trans-pedal or trans-tibial retrograde angioplasty after failure of the traditional ante-grade angioplasty with the aid of US, 21-gauge needle and 0.018 wire through sheath-less approach as a last chance for revascularization
详细描述
Study Design: This prospective non randomized study that had been performed at vascular surgery department at Mansoura University Hospital between March 2018 and April 2020, who was selected for 96patients undergoing endovascular BTK revascularization for CLI owing to tibial vascular diseases and gave written informed consent. Such cases who not give good response following traditional ante-grade ipsilateral trans-femoral approach and consequently underwent retrograde Trans-pedal or transtibial access to provide endovascular management for the lesions.
Inclusion criteria:
- all patients aged from (18-80) years, males and female
- patients with 1ry lesion (without previous trial of angioplasty or bypass)
- 2ry lesion (after previous trial of angioplasty or bypass),
- the patients with fountain classification (stage IIB, stage III, stage IV)
- patients with Rutherford classification (grade I "category 3", grade II, Category 4", grade III, Category 4&category 5.
Exclusion criteria:
- patients with untreated osteomyelitis,
- patients with mixed lesions with other comorbidities (CVI & Lymphoedema),
- patients with vasculitis or Buerger's dis.
- Also, who can't give consent (mentally retarded patients) or those with behavioral disorders .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients aged from (18-80) years, males and female
- •patients with 1ry lesion (without previous trial of angioplasty or bypass)
- •2ry lesion (after previous trial of angioplasty or bypass),
- •the patients with fountain classification (stage IIB, stage III, stage IV)
- •patients with Rutherford classification (grade I "category 3", grade II, Category 4", grade III, Category 4&category
- •Exclusion criteria:
- •patients with untreated osteomyelitis,
- •patients with mixed lesions with other comorbidities (CVI & Lymphoedema),
- •patients with vasculitis or Buerger's dis.
- •Also, who can't give consent (mentally retarded patients) or those with behavioral disorders .
排除标准
- 未提供
结局指标
主要结局
amputation free survival rates
时间窗: one year
limb salvage after precedure
primary patency
时间窗: one year
patency of the vessels after intervention
30 days' mortality and morbidity.
时间窗: 30 days
major adverse effects related to procedure
次要结局
未报告次要终点