NCT01646788Unknown不适用
Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae
N.M.B. Medical Applications Ltd1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Restenosis rate
研究概览
简要总结
The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) for the treatment of obstructive lesions of Arteriovenous (AV) Dialysis Fistulae/Grafts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patient is 18 years old or older.
- •Native arteriovenous fistula or synthetic arteriovenous access graft performed/implanted more than 45 days before enrollment and at least one successful hemodialysis session performed.
- •Patient having obstructive lesion of native or synthetic arteriovenous dialysis fistulae/grafts, suitable for PTA procedure.
- •Patient who is willing and able to sign a written informed consent and that complies with procedures (including adherence to follow-up visits).
排除标准
- •Women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception.
- •Previous participation in another study with any investigational drug or device within the past 30 days.
- •Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult.
- •Known hypersensitivity to paclitaxel or structurally-related compounds.
- •Severe reaction to contrast agents that cannot be adequately premedicated prior to procedure.
- •Stenosis with corresponding thrombosis treated within 7 days before enrollment.
- •Patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy.
- •Infected grafts/fistulae.
结局指标
主要结局
Restenosis rate
时间窗: 6 months
Binary Stenosis is defined as ≥50% narrowing in luminal diameter basen upon comparison with the adjacent normal vessel. Restenosis Rate - comparison shall be performed both to the patient previous data as well as to restenosis rate data published in the literature for standard PTA balloon catheter procedure
次要结局
- restenosis rate(1, 3 and 12 months)
- Easy insertion and removal(intraprocedural)
- Major adverse events rate(intraprocedural 1, 3, 6 and 12 months)
研究者
研究点 (1)
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