NCT03024372撤回不适用
A Prospective Randomized Single Blinded Study of Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Time to loss of primary patency
研究概览
简要总结
The purpose of this study is to investigate a promising strategy to improve maturation and patency rates following creation of AV fistulas and assess whether an anastomosis performed with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency than one performed with conventional suturing techniques.
详细描述
This will be a single blind (patient and dialysis center), prospective, randomized trial conducted at a single center. The study intervention will be randomization between conventional sutured anastomosis (Control group) and use of Anastoclips (Treatment group), which provide an interrupted closure without intimal penetration.
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
- •Requiring brachiocephalic fistula judged to be best option for access after vein mapping (Surgeons will be required to do 10 cases using Anastoclips prior to enrolling)
- •Able to provide informed consent in English or Spanish
- •Age 18 years or greater
- •With estimated life expectancy of 2 years or more
- •Able to comply with study procedures including all scheduled follow-up visits
排除标准
- •Unable to provide informed consent in English or Spanish
- •Age < 18 years
- •With pacemaker, IACD, or other permanent obstructive device on that side (a temporary tunneled dialysis catheter is not an exclusion)
- •Unable (or in surgeon's judgment a poor risk) to comply with study procedures and follow-up visits
- •With estimated life expectancy of less than 2 years
- •Females must be either:
- •Of non-childbearing potential, which is defined as post-menopausal (at least 12 months without menses prior to Treatment Day) or documented surgically sterile or post hysterectomy (at least 1 month prior to Treatment Day)
- •Or, of childbearing potential, in which case must have a negative urine pregnancy test at Treatment Day
结局指标
主要结局
Time to loss of primary patency
时间窗: one year post surgery
次要结局
- Time to functional maturation(one year post surgery)
- Time to assumed maturation(one year post surgery)
- Operative cost(duration of surgery)
- Time to loss of secondary patency(5 years post surgery)
- Rate of functional maturation(one year post surgery)
- Rate of complications(30 days post surgery)
- Time to loss of primary patency(5 years post surgery)
- Time to loss of assisted primary patency(5 years post surgery)
- Rate of assumed maturation(one year post surgery)
- Rate of intervention(five years post surgery)
- Overall cost(time of surgery to time of hospital discharge (can range from 1 day to 1 week or more))
研究者
研究点 (6)
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