A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon PTA Catheter for Treatment of Dysfunctional Native and Synthetic AV Fistulae
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 26
- 主要终点
- Proportion of subjects with target lesion primary patency
研究概览
简要总结
The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.
详细描述
This post market registry is intended to demonstrate safety and assess the clinical use and outcomes of the Lutonix DCB in a heterogeneous patient population with dysfunctional native or synthetic AV fistulae in real world clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Male or non-pregnant, non-breastfeeding female ≥18 years of age;
- •Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits;
- •Native or synthetic (grafts) arteriovenous fistula located in the arm, including central veins, presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines; and
- •Lesion(s) can be treated with available Lutonix DCB device size matrix per current IFU.
排除标准
- •Patients will be excluded if ANY of the following conditions apply:
- •Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix Global AV registry).
- •Patient has a non-controllable allergy to contrast; or
- •Patient has another medical condition that, which in the opinion of the Investigator, may confound the data interpretation of is associated with a life expectancy insufficient to allow for completion of patient registry procedure and follow up.
结局指标
主要结局
Proportion of subjects with target lesion primary patency
时间窗: 6 Months
Defined as the interval following index procedure until clinically-driven reintervention of the target lesion or access thrombosis, through 6 months. Clinically-driven reintervention is defined as a lesion that has ≥50% stenosis and at least one clinical, physiological or hemodynamic abnormality attributable to the stenosis defined in the K/DOQI guidelines.
Proportion of subjects with freedom from any serious adverse event(s) involving the AV access circuit
时间窗: 30 days.
Primary safety events include any serious adverse event(s) involving the AV access circuit
次要结局
- Proportion of subjects with access circuit primary patency at 3, 6, and 12 months(12 months)
- Proportion of Subjects with Device Success(12 Months)
- Proportion of Subjects with Abandonment of permanent access in the index extremity(12 months)
- Proportion of Subjects withTarget Lesion Primary Patency (TLPP)(12 months)
- Proportion of Subjects with Procedural Success(12 Months)
- Proportion of Subjects with Clinical Success(12 Months)
- Rate of device and procedure related adverse events(12 months)