Allografts in Surgery of the Main Arteries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of Participants with lethal outcomes
研究概览
简要总结
The study will examine the results of the use of biological materials (allogeneic arterial grafts, allogeneic venous graft, autologous vein, biological bovine decellularized graft) as a bypass grafts for reconstructive interventions in patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease in the short-term and long-term postoperative periods. Histological analysis of allogeneic grafts will be carried out at various time points of graft preservation with a Roswell Park Memorial Institute 1640 cell medicum with 400mcg/ml gentamicin and 20mcg/ml fluconazole at a temperature of +4C.
The physical properties of allogeneic grafts from postmortem donors (tensile and tear strength) will be evaluated at various conservation time periods (1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks). Markers of endothelial dysfunction (IL-6, endothelin-1, 6-keto-prostaglandin F1alfa, eNOS) will be evaluated in patients with critical ischemia who undergo bypass procedures with arterial and venous allografts at various time points (before surgery, 7 days, 1 month, 3 months, 6 months, 1 year after).
详细描述
The study will include 200 patients of similar age, gender, and ethnicity, who will be divided into four groups:
Group I: 50 patients who undergo arterial bypass procedures using autologous venous graft derived from great saphenous vein; Group II: 50 patients who undergo arterial bypass procedures using allogeneic venous grafts; Group III: 50 patients who undergo arterial bypass procedures using allogeneic arterial grafts; Group IV: 50 patients using biological bovine decellularized grafts.
Patients will be monitored for 2 years: at inclusion, and 1, 3, 6, 12, 18, and 24 months after bypass procedures.
The primary endpoint of the study will be mortality, i.e. death of the patient from any cause. Secondary endpoints of the study will be graft thrombosis and cardiovascular events such as myocardial infarction, acute coronary syndrome, transient ischemic attack, and stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •males or females over 18 years of age;
- •critical lower limb ischemia due to atherosclerotic peripheral arterial disease.
排除标准
- •males or females less than 18 year of age;
- •decompensated concomitant pathology;
- •pregnancy or lactation.
结局指标
主要结局
Number of Participants with lethal outcomes
时间窗: 24 months
The primary outcome measure is mortality rate
次要结局
- Myocardial infarction(1, 3, 6, 12, 18, and 24 months)
- Number of Participants with Stroke or transient ischemic attack(24 months)
- Number of Participants with Graft thrombosis(24 months)
- Number of Participants with Acute coronary syndrome(24 months)