Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 124
- 主要终点
- Fistula used successfully for haemodialysis (FUSH)
研究概览
简要总结
The purpose of this randomised clinical trial is to evaluate the efficacy of drug-eluting balloon compared to conventional balloon in balloon-assisted maturation of non-maturing arteriovenous fistula in adult renal failure patients.
详细描述
This is a single-centre study, where a total of 124 subjects with non-maturing arteriovenous fistula will be randomised (1:1) to either experimental or active comparator arm. Randomisation will be stratified by location of arteriovenous fistula (above versus below elbow).
Each subject will undergo fistulogram in order to assess eligibility criteria. In the event that there is more than 1 eligible stenosis, the most severe stenosis will be considered the target (study) lesion. All other lesions will be treated in the conventional manner. No coil embolisation of collaterals will be performed in the index treatment.
If the subject is allocated to the experimental arm, the target lesion will be treated with pre-dilatation with a conventional balloon before application of the drug-eluting ballon.
If the subject is allocated to the active comparator arm, the target lesion will be treated with a conventional balloon.
High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%).
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
The participants, referring physicians, outcomes assessors and data analysis team will be masked. The procedurist will not be masked since it is not possible to perform the procedure without masking. The procedurist will not be involved in outcomes assessment.
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
- •Non-maturing upper limb arteriovenous fistula (AVF) created 6-24 weeks ago with any one of the following:
- •Non-maturing on physical examination, or
- •Failed initial cannulation, or
- •Failure to achieve prescribed dialysis within prescribed time frame.
- •Stenosis (>50%) along AVF circuit from anastomosis up to, but not including, the subclavian vein.
- •Successful guidewire crossing of target lesion.
- •>= 21 years old.
- •Informed consent given.
- •Patient willing and able to return for 3 month, 6 month fistulogram and 12 month clinic follow up.
排除标准
- •Thrombosed non-maturing AVF
- •Target lesion is longer than 8 cm
- •Previous endovascular therapy for non-maturation of the trial AVF
- •Baseline systolic blood pressure less than 100 mmHg
- •Non-maturing AVF is not planned to be used for dialysis in the immediate future (e.g. chronic kidney disease not requiring haemodialysis yet)
- •Coagulopathy (prothrombin time or activated partial thromboplastin time >1.5 times the median of normal range) that cannot be managed adequately with periprocedural transfusion
- •Thrombocytopenia (platelet count <50,000 /μL) that cannot be managed adequately with periprocedural transfusion
- •Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication
- •Allergy / contraindication to dual anti-platelet therapy (aspirin and clopidogrel or ticlopidine) or paclitaxel
- •Acute infection over proposed puncture site
- •Women who are breastfeeding, pregnant or planning on becoming pregnant during study.
- •Men who are planning on fathering children during the study.
- •Participant with medical conditions which in the opinion of the investigator may cause non-compliance with protocol.
- •Currently participating in an investigational drug, biologic or device trial that may have an impact on the AVF or previous enrollment in this study.
结局指标
主要结局
Fistula used successfully for haemodialysis (FUSH)
时间窗: 3 month
FUSH is met if the fistula can be used with two-needle cannulation for two-thirds or more of all dialysis runs for 1 month and if it delivers the prescribed dialysis within the prescribed time frame.
次要结局
- Target lesion anatomic success(At the end of index procedure)
- Time from intervention to first successful haemodialysis with two-needle cannulation(Up to 12 months)
- Target lesion percent stenosis at 6-month fistulogram(At 6 months)
- Target lesion restenosis rate at 6-month fistulogram(At 6 months)
- Number of repeat interventions to target lesion at 6 months(At 6 months)
- Number of repeat interventions to target lesion at 12 months(At 12 months)
- Number of repeat interventions to access circuit at 6 months(At 6 months)
- Number of repeat interventions to access circuit at 12 months(At 12 months)
- Post intervention target lesion patency(Up to 12 months)
- Post intervention access circuit primary patency(Up to 12 months)
- Post intervention access circuit assisted primary patency(Up to 12 months)
- Post-intervention access circuit secondary patency(Up to 12 months)
- Complication rates(At 12 months)