ISRCTN14567609已完成3 期
Improving outcomes in fistula intervention: A prospective, patient blinded, phase III, randomised controlled trial of drug eluting balloons in the angioplasty of native haemodialysis access arterio-venous fistula outflow stenosis
niversity Hospital Birmingham NHS Foundation Trust0 个研究点目标入组 92 人开始时间: 2016年1月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Arteriovenous (AV) fistulas with stenosis requiring percutaneous angioplasty identified on routine diagnostic imaging or causing clinical concern on dialysis
- •2. Fistula has been in use for at least 1 month and is more than 6 weeks old
- •3. Brachiocephalic AV fistula
- •4. Brachiobasilic AV fistula
- •5. Radiocephalic AV fistula (both proximal and distal)
- •6. Aged 18 years or over
- •7. 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)
- •8. Capacity to give valid informed consent
排除标准
- •1. Allergy to iodinated Intravenous contrast
- •2. Allergy to Paclitaxel
- •3. Prosthetic grafts
- •4. Long or tandem lesions that cannot be treated with a single DEB
- •5. Thrombosed ArterioVenous fistulas
- •6. Women who are breastfeeding, pregnant or intending to become pregnant
- •7. Participants of childbearing age who are unwilling to use a reliable form of contraception for the duration of the study
研究者
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