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临床试验/NCT01970605
NCT01970605已完成不适用

Silver Graft All Comers Registry is to Assess the Long Term Clinical Benefit of Silver Graft in an Unselected Patient Population

B. Braun Melsungen AG1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2013年10月最近更新:
适应症

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:

  1. 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

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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