FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Incidence of primary patency of the venous bypass
研究概览
简要总结
The purpose of this clinical trial is to analyze patency after autologous infrainguinal bypass surgery in patients receiving a venous conduit versus a covered venous conduit.
详细描述
Patients presenting to Vascular Surgical Units are usually multimorbid with increased cardiopulmonary risk. Autologous venous bypass is indicated in certain situations despite the longer duration of surgery. Optimizing patency has been an important goal since many years. Reconstruction problems are often based on intimal hyperplasia, which can be reduced via covering of the harvested vein as seen in previous studies.
This clinical trial will be conducted at our Division of Vascular Surgery and Endovascular Surgery at the University Hospital of Salzburg. Patients will be randomized into one of the two treatment options, which are a plain venous conduit or a by mesh covered venous conduit. During this clinical trial, the first follow-up will take place after 6 weeks; this corresponds to the usual follow-up interval. Due to the trial, further follow-ups will take place for each of the patients after 3 months, 6 months, 12 months, 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Age at least 18 years
- •Informed consent form with signature
- •Rutherford Category 3 (<200m) or chronic critical ischemia (Rutherford Category 4-6)
- •Assured inflow and recipient artery.
排除标准
- •Pregnant or breastfeeding women
- •Active infection or sepsis
- •Acute ischemia
- •Endovascular procedure in the region to be treated.
- •Vein with outer diameter <3.5 mm or >8 mm under pressure.
- •Spliced Veins.
- •Known allergy to the cobalt-chromium alloy (ASTM 1058) or its components (Cobalt-Chromium-Iron-Nickel-Molybdenum).
- •Vasculitis
- •Coagulopathy
- •Radiation therapy near the anastomosis
结局指标
主要结局
Incidence of primary patency of the venous bypass
时间窗: 2 years
The incidence of patency of the venous bypasses will be analysed and compared. This is defined as freedom from occlusion of the venous bypass.
次要结局
- Incidence of limb salvage after procedure(2 years)
- Incidence of procedure-related mortality(2 years)
- Incidence of 30-day mortality(30 days)
研究者
Klaus Linni
Head of Division of Vascular and Endovascular Surgery, MD PD
Paracelsus Medical University