The Role of Hemostatic Markers of Endothelial Dysfunction in the Development of Disease Progression, Thrombotic Complications and Restenosis in Patients With Atherosclerotic Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 主要终点
- progression of atherosclerosis
研究概览
简要总结
The study is aimed at evaluating the role of the activity of the key hemostatic parameters of endothelial dysfunction (nitric oxide II (NO) metabolites, plasmin activator inhibitor-1 (PAI-1), von Willebrand factor (vWF), coagulation factor VIII (FVIII), soluble endothelial protein C receptors (sEPCR)) in the development of disease progression, thrombotic complications and restenosis in subjects with atherosclerotic peripheral artery disease.
详细描述
The study will involve patients with atherosclerotic peripheral artery disease (Rutherford category 3-5). The subjects are to be divided into three groups:
Group A: patients who undergo bypass surgery with a synthetic graft on aorto-iliac or femoro-popliteal segment; Group B: patients who undergo endovascular balloon angioplasty and stenting on aorto-iliac or femoro-popliteal segment; Group C: patients who undergo standard of care conservative treatment.
Decisions on revascularization or conservative treatment alone is to be made by a team of vascular specialists in accordance with the severity of the disease, previous treatment, anatomy, possible need for repeat procedures in the future, and patient's preferences.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females older than 40 years of age;
- •Presence of peripheral arterial disease of atherosclerotic origin.
排除标准
- •Males or females younger than 40 years of age;
- •Chronic lower limb ischemia of other ethiology (Buerger's disease, aortoarteritis etc.);
- •Active cancer or remission period less than 5 years;
- •Decompensated diabetes mellitus;
- •Pregnancy or breast-feeding for females.
结局指标
主要结局
progression of atherosclerosis
时间窗: 1 year
detection of newly formed or progressing peripheral atherosclerotic lesions
restenosis
时间窗: 1 year
incidence of restenosis in the target arterial segment
thrombosis
时间窗: 1 year
incidence of thrombotic complications in the target arterial segment
次要结局
- limb salvage rate(1 year)
- acute myocardial infarction(1 year)
- mortality rate(1 year)