NCT06553443招募中3 期
Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Access circuit primary patency
研究概览
简要总结
To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty
详细描述
This is a blinded randomized controlled trial recruiting 94 patients with AVF stenosis who will be randomized in a 1:1 ratio to either drug-coated balloon (Ranger) or conventional balloon. All peripheral AVF stenoses will be treated with the allocated balloon type.
The primary outcome measure is 6-month access circuit patency.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
All are blinded except procedurist and protocol administrator.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted.
- •AVF has been used successfully for at least 1 month (non-mature AVF are not allowed).
- •Less than 30% residual stenosis after angioplasty.
- •≥ 21 years old
- •Informed and valid consent given.
排除标准
- •Thrombosed AVFs
- •Haemodynamically significant central vein stenosis
- •Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm)
- •Contraindication to antiplatelet therapy
- •Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion.
- •Allergy / contraindication to paclitaxel.
- •Acute infection over proposed puncture site.
- •Women who are breastfeeding, pregnant * or planning on becoming pregnant during study.
- •Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol.
- •Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.
结局指标
主要结局
Access circuit primary patency
时间窗: 6 months
Time to next clinically-driven intervention
次要结局
- Procedural complication(12 months)
- Access circuit secondary patency(6 and 12 months)
- Access access circuit patency(12 months)
- Access circuit assisted primary patency(6 and 12 months)
- Mortality(12 months and 5 years)
研究者
研究点 (1)
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