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临床试验/NCT00737620
NCT00737620已完成4 期

Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis

Shaare Zedek Medical Center1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
160
试验地点
1
主要终点
Patency of AV fistula

研究概览

简要总结

The majority of bridge graft fistula with polytetrafluoroethylene (PTFE) for hemodialysis access will develop stenosis at the venous anastomosis and eventually will fail. Aspirin have been used for many years as a prophylactic drug therapy to prevent thrombosis but good clinical evidence for its benefit is lacking. Many drugs have been used to reduce intimal hyperplasia in animal models. Until recently there has been little success in clinical trials of anti-inflammatory, antiproliferative, antiplatelet, antithrombotic or calcium channel blocking drugs. Recently a major breakthrough was done by GORE when introducing the new heparin bonded PTFE graft by covalent attachment. This trial is planed to assess and compare between the GORE-TEX® PROPATEN vascular graft versus unmodified ePTFE grafts the patency and complication.

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

入选标准

  • All the patients who are scheduled for the creation of a new prosthetic access with informed consent will be enrolled in the trial
  • Investigators will attempt to enroll a male:female ratio of patients representative of their current patient population

排除标准

  • Anticoagulation therapy

结局指标

主要结局

Patency of AV fistula

时间窗: Study period

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr David Shemesh

Dr

Shaare Zedek Medical Center

研究点 (1)

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