NCT01033357终止不适用
A Long Term Safety Study of the Vascular Wrap(TM) Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® Graft in the Upper Extremity for Hemodialysis Vascular Access
Angiotech Pharmaceuticals59 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2008年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 222
- 试验地点
- 59
- 主要终点
- Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events
研究概览
简要总结
The purpose of this study is to determine whether the long term use of the experimental Vascular Wrap(TM) Paclitaxel-Eluting Mesh is safe in the treatment of subjects needing hemodialysis access (via an expanded polytetrafluoroethylene (ePTFE) graft).
详细描述
The primary objective of this study is to determine long term safety of the Lifespan® ePTFE Vascular Graft and Vascular Wrap(TM) Paclitaxel-Eluting Mesh in comparison to the Lifespan® graft alone.
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
- Single (Participant)
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
- •To be considered for enrollment, subjects must:
- •have been randomized in protocol 012-VWAV06;
- •have signed and dated an IRB-approved written informed consent to participate in 012-VWAV06 as well as this study;
- •be willing to comply with all aspects of the evaluation schedule over a period of 60 months post device insertion;
- •allow representatives of the sponsor, designated Clinical Research Organization (CRO), Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records.
排除标准
- •Subjects who withdrew or were withdrawn from study 012-VWAV06.
结局指标
主要结局
Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events
时间窗: 4 years
次要结局
未报告次要终点
研究者
研究点 (59)
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