Randomized Clinical Study to Evaluate the Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter in Treatment of Arteriovenous Dialysis Access Circuit Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 5
- 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
研究组 & 干预措施
Cook Enforcer balloon catheter
The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
干预措施: Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (Device)
Conventional angioplasty balloon catheters
Commercially available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
干预措施: Conventional angioplasty balloon catheters (Device)
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