Retrograde Approach for Management of Infrainguinal Arterial Occlusive Disease After Failed Antegrade Approach in Critical Limb Ischemia Patients; Feasibility, Safety, and Procedure Related Outcomes.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- safety of retrograde approach as regard occurrence of procedure specific complications
研究概览
简要总结
The spectrum of lower extremity peripheral arterial disease (PAD) ranges from exhibiting no symptoms to limb threatening gangrene. The number of patients living with it is rising steadily owing to increased life expectancy, obesity, diabetes, and tobacco consumption.
Critical limb ischemia (CLI) is the terminal and the most serious stage of PAD in which blood flow to the lower extremity does not meet metabolic demands of the tissues at rest. The diagnosis is mainly clinical and patients are presented with rest pain, minimal tissue loss or frank gangrene.
Revascularization strategies include endovascular procedures and surgical bypass.Endovascular therapy has evolved as an attractive, minimally invasive method of revascularization especially in the more frequently encountered patients with medical and anatomical contraindications to surgical revascularization.
Antegrade approach is the standard approach in infrainguinal arterial occlusive disease,however, failure occurs in about 20% of infrainguinal attempts.Retrograde approach is used as a backup technique in failed cases.
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
- 35 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with;
- •CLI consistent with Rutherford categories (4-5).
- •Infrainguinal arterial occlusive disease with a patent distal part of at least one tibial vessel runoff to the foot.
排除标准
- •patients with the following conditions will be excluded:
- •Non-salvageable limbs.
- •Life threatening infections requiring major amputation.
- •Ulcers at the area of intended puncture.
结局指标
主要结局
safety of retrograde approach as regard occurrence of procedure specific complications
时间窗: within one year of follow up
safety of retrograde approach after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease, in the light of complications which are classified into major or minor according to the reporting standards of society of vascular surgery.this complications will be looked for and data will be collected
feasibility of retrograde approach as regard successful retrograde puncture and technical success after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease.
时间窗: within one year of follow up
it means that this approach can be used successfuly in clinical practice and this will be assessd by measuring successful retrograde puncture and technical success. successful retrograde puncture means successful performance of retrograde puncture at any of the retrograde distal puncture sites with intraluminal placement of the retrograde guidewire confirmed by contrast angiography without causing procedure specific complications namely local dissection, rupture, or an arteriovenous fistula at puncture site. technical success is defined as successful puncture followed by successful crossing of the occlusion and regain of inline flow to the foot with less than 30%residual stenosis after treatment.
次要结局
- clinical success of the procedure(within one year of follow up)
- One year limb salvage rate of the procedure(within one year of follow up)
研究者
Mostafa Abdelmagied Ragb Fouda
assistant lecturer in the department of vascular surgery
Sohag University