NCT03552289已完成不适用
Randomized Clinical Study to Evaluate the Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter in Treatment of Arteriovenous Dialysis Access Circuit Stenosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 10
- 主要终点
- Percent of Lesions Requiring Adjunctive Treatment
研究概览
简要总结
The purpose of this study is to evaluate the performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional angioplasty balloon.
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
- None
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
- •Clinical or physiological abnormalities which indicate dialysis access dysfunction (e.g., decreased access blood flow, elevated venous pressure, decreased dialysis dose, abnormal physical exam)
排除标准
- •Less than 18 years old
- •Pregnant, lactating, or planning to become pregnant in the 3 months following enrollment
- •Underwent any surgical or interventional procedure of the access circuit less than or equal to 30 days prior to enrollment
- •Scheduled for a kidney transplant
- •Stent or stent graft in the arteriovenous (AV) dialysis access circuit
结局指标
主要结局
Percent of Lesions Requiring Adjunctive Treatment
时间窗: Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour
Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon
次要结局
未报告次要终点
研究者
研究点 (10)
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