NCT02902094Unknown不适用
Improving Outcomes in Fistula Intervention: A Prospective, Patient Blinded, Phase 3, Randomised Controlled Trial of Drug Eluting Balloons in the Angioplasty of Native Haemodialysis Access Arteriovenous Fistula Outflow Stenosis (DeVA)
University Hospital Birmingham2 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2016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
- 186
- 试验地点
- 2
- 主要终点
- Patency
研究概览
简要总结
DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native AV fistula stenosis.
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
- •Arteriovenous (AV) fistulas with stenosis requiring percutaneous angioplasty identified on routine diagnostic imaging or causing clinical concern on dialysis.
- •Fistula has been in use for at least 1 month and is > 6 weeks old
- •Brachiocephalic AV fistula
- •Brachiobasilic AV fistula
- •Radiocephalic AV fistula (both proximal and distal)
- •Participant >/=18 yrs old
- •Index lesion is less then the length of the DEB, and the reference vessel diameter is appropriate for treatment with the size range of DEB (4mm - 8mm diameter)
- •Participant is able to give valid informed consent
排除标准
- •Allergy to iodinated Intravenous contrast
- •Allergy to Paclitaxel
- •Prosthetic grafts
- •Long or tandem lesions that cannot be treated with a single DEB
- •Thrombosed Arterio-Venous fistulas
- •Women who are breastfeeding, pregnant or intending to become pregnant
- •Participants of child-bearing age who are unwilling to use a reliable form of contraception for the duration of the study.
结局指标
主要结局
Patency
时间窗: 12 months
Primary end point is a composite of one or more of : * \>50% stenosis of index lesion requiring re-intervention * Re-intervention of index lesion due to clinical indications without 50% re-stenosis * Fistula failure
次要结局
- Technical success(Time of baseline index intervention)
- Assisted technical success of balloon angioplasty(At time of baseline index intervention)
- Successful use of fistula for dialysis(In the 12 months following baseline index intervention)
- Secondary patency of the access circuit(In the 12 months following baseline index intervention)
研究者
研究点 (2)
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