Silver Graft All Comers Registry is to Assess the Long Term Clinical Benefit of Silver Graft in an Unselected Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- graft patency
研究概览
简要总结
This web based e-Registry will be international, multi-center and prospective. Silver Graft e-Registry to assess the long term clinical benefit of Silver Graft in an unselected patient population
详细描述
To assess the long term clinical benefit of Silver Graft in an unselected patient population with Peripheral Artery Occlusive Disease (PAOD) fulfilling one of the the following criteria:
- Any suitable patient in need of an infrarenal vascular reconstruction with Fontaine class IIb or indicated vascular reconstruction aneurysm repair.
or 2. Any suitable patient with an increased risk for early graft failure except those mentioned under (3). These may include
- diabetics
- Fontaine class> IIb
- patients of advanced age (≥75 y)
- patients with renal insufficiency (creatinine ≥ 1.50 mg/dl or ≥130 µmol/l)
- patients with COPD or documented coronary artery disease (prior PCI, prior CABG, documented myocardial ischemia)
- patients with major amputation
- immunosuppressed patients
- patients with autoimmune disease, malignancy
or 3. Any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any suitable patient in need of an infrarenal vascular reconstruction with Fontaine class IIb or indicated vascular reconstruction aneurysm repair.
- •Any suitable patient with an increased risk for early graft failure except those mentioned under (3). These may include
- •diabetics
- •Fontaine class> IIb
- •patients of advanced age (≥75 y)
- •patients with renal insufficiency (creatinine ≥ 1.50 mg/dl or ≥130 µmol/l)
- •patients with COPD or documented coronary artery disease (prior PCI, prior CABG, documented myocardial ischemia)
- •patients with major amputation
- •immunosuppressed patients
- •patients with autoimmune disease, malignancy
- •Any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction.
排除标准
- •Any patient with common contraindications for vascular surgery may not be included in this registry.
- •Any patient with an estimated life expectancy less than the first follow-up period, i.e. 12 months is excluded from data entry.
- •Any patient with a known and documented allergy to silver or silver ions.
结局指标
主要结局
graft patency
时间窗: 12 months
12-month patency assessed with duplex ultrasound
次要结局
- Freedom from infection(at 12 months)
