A Randomized Trial Comparing Drug-coated Balloon and Regular Balloon for Dialysis Access Stent Graft Restenosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Late luminal loss
研究概览
简要总结
Recurrent stenosis in hemodialysis access graft (AVG) is difficult to treat. For recurrent stenosis in the anastomotic junction can be treated by stent graft to improve long-term patency. However, there is no data regarding treatment of stent graft restenosis in AVG. This randomized trial is designed to compare the efficacy and safety of drug-coated balloon (DCB) versus regular balloon in AVG stent graft restenosis.
详细描述
Prosthetic arteriovenous hemodialysis access graft (AVG) has high incidences of venous anastomotic stenosis and access failure. A stent graft can be used in AVG with recurrent venous anastomotic stenosis to improve long-term patency rate. However, after stent graft implementation, the effective treatment for restenosis in a stent graft is still unknown. This randomized trial is designed to evaluate the efficacy and safety of drug-coated balloon versus regular balloon for in-stent restenosis in stent graft. The investigators plan to enroll 40 patients who presented with prosthetic AVG in-stent restenosis, and then to evaluate the restenosis lesions by intravascular ultrasound. Patients will be randomized into two groups of treatment: drug-coated balloon angioplasty or regular balloon angioplasty.
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 (Outcomes Assessor)
盲法说明
The IVUS interpreter and follow-up evaluators are masked.
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 20 to 90 years on regular hemodialysis at least 3 months
- •Had stent graft implemented at dialysis vascular access
- •Angiographic evidence of stenosis within the stent graft or less than 2 cm from the stent graft edge
- •Clinical evidence of a hemodynamically significant stenosis or thrombosis
- •Patient is able to provide written informed consent
排除标准
- •Elbow fracture or any disease involve the elbow joint that prohibits the flexion maneuver.
- •Target lesion cannot be crossed by the guide wire.
- •Known hypersensitivity to heparin or contrast medium.
- •Bleeding diathesis.
- •Patients participating in another clinical trial with interfering with this trial in the past three months.
- •Untreatable bleeding diathesis.
- •Other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patient's life expectancy (less than 3 months).
- •Patients unable or unwilling to participate this trial.
- •Pregnancy, lactating woman, non-adult, criminals in sentence, psychiatric patients, research staffs or colleagues are prohibited.
研究组 & 干预措施
Regular balloon
Use the regular balloon to perform standard balloon angioplasty.
干预措施: Regular balloon (Device)
DCB (paclitaxel-coated balloon)
Use DCB (paclitaxel-coated balloon) to perform additional balloon angioplasty.
干预措施: DCB (paclitaxel-coated balloon) (Device)
结局指标
主要结局
Late luminal loss
时间窗: 0, 1, and 3 months
The late luminal loss found by IVUS on follow-up in comparison to index procedure.
次要结局
- minimal luminal area and diameter(0, 1, and 3 months)
- repeated intervention(0, 1, and 3 months)
- abandon of AV graft, death(0, 1, and 3 months)
- restenosis rate(0, 1, and 3 months)
研究者
IRB of NTUH Hsin-Chu Branch
Mu-Yang Hsieh MD
National Taiwan University Hospital Hsin-Chu Branch