A Prospective, Multicenter, Single Arm, Post-Market, Real-World Global Registry Assessing the Clinical Use and Safety of the LUTONIX Drug Coated Balloon Catheter in Arteries of the Lower Extremity (LUTONIX® Lower Extremity Global (LEG) Registry)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 59
- 试验地点
- 8
- 主要终点
- Efficacy: Freedom from target lesion revascularization (TLR)
研究概览
简要总结
The registry will enroll patients with claudication or critical limb ischemia and angiographically significant lesion(s) in arteries of the lower extremity. Subjects will be treated with the Lutonix® Drug Coated Balloon Catheter for approved indications according to the current country-specific Instructions for Use (IFU) and followed clinically for 1 year.
详细描述
This post-market registry is intended to assess the clinical use and safety of the Lutonix® Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice. Up to 500 patients will be enrolled in order to allow identification and assessment of rare adverse events (AEs) as well as outcomes in subpopulations defined by subject and lesion characteristics. All subjects will be followed for 1 year.
This registry is performed with marketed devices within the indications for use. There are no additional treatments or exams that will take place within this registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •≥ 18 years of age;
- •Rutherford Clinical Category ≤ 5;
- •Patient or Legally Authorized Representative is willing to provide informed consent and comply with the required follow up;
- •Stenotic or obstructive vascular lesions in artery(s) of the lower extremity;
- •Lesion(s) can be treated with available LUTONIX Drug Coated Balloon Catheter device size matrix per current country-specific IFU.
排除标准
- •Patient is currently participating in an active phase of another investigational drug or device study;
- •Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast.
结局指标
主要结局
Efficacy: Freedom from target lesion revascularization (TLR)
时间窗: 12 months
Safety
时间窗: 30 Days
Freedom from the composite endpoint of target vessel revascularization (TVR), major amputation and major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of index limb and device- and procedure-related death.
次要结局
- Procedural Success(30 days, 6 and 12 months)
- Freedom separately from each of the following adverse events listed below:(30 days, 6 and 12 months)
- Acute Device Success(30 days, 6 and 12 months)