NCT05101512Unknown不适用
Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Survival rate of patients at 2 years with lower limb rescue
研究概览
简要总结
The main objective of this study is to assess the 2-year survival with salvage of the lower limb of patients who have undergone subgonal bypass grafting by venous allograft in the treatment of Occlusive Peripheral Arterial Disease (OPAD) in critical ischemia, in the absence of usable great saphenous vein.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman over 18 (under effective contraception, hormonal contraceptive or intrauterine device, if premenopausal).
- •Patient with critical ischemia of the lower limb (stage 4-5-6 according to the Rutherford classification) requiring revascularization by sub-gonal bypass
- •Patient eligible and scheduled for bypass in venous allograft stored at + 4 ° C with distal anastomosis below the knee
- •Patient without usable autologous great Saphenous vein
- •Subject affiliated or beneficiary of a social security scheme
- •Patient having received the appropriate information concerning the objectives and procedures of the study and having declared his non-objection.
排除标准
- •Use of unscheduled allografts
- •Patient requiring composite bypass in AGV + autologous venous material or prosthesis
- •Patient requiring replacement of infected prostheses
- •Patient with acute ischemia
- •Patient with severe coagulation disorders
- •Patient classified physical status score 4
- •Patient participating in another clinical trial
- •Potential allergy to the graft
- •Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Patient with critical ischemia of the lower limb
Experimental
Patient eligible and scheduled for bypass in venous allograft stored at + 4 ° C with distal anastomosis below the knee
干预措施: Questionnaires on quality of life after surgery (Behavioral)
结局指标
主要结局
Survival rate of patients at 2 years with lower limb rescue
时间窗: 2 years
survival rate of patients at 2 years with lower limb rescue (time until death or amputation - amputation free survival)
次要结局
未报告次要终点
研究者
研究点 (1)
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